ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement

March 21, 2024 updated by: Boston Scientific Corporation

ACURATE IDE: Transcatheter Replacement of Stenotic Aortic Valve Through Implantation of ACURATE in Subjects InDicatEd for TAVR

To evaluate safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Subjects will be enrolled at up to 85 centers in the United States, Canada, Europe, and Australia. There will be up to 2,820 subjects in ACURATE IDE.

The ACURATE IDE study cohorts include the following.

  • Main Randomized Cohort: A prospective, multicenter, 1:1 randomized controlled trial (RCT; ACURATE versus a commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration [SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA] or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration [CoreValve; Medtronic, Inc., Dublin, Ireland]). There will be up to 1,500 subjects in the RCT.
  • Roll-In Cohort: A non-randomized roll-in phase with the test device. Centers that do not have implantation experience with the ACURATE neo™ Aortic Bioprosthesis (transfemoral delivery; Boston Scientific Corporation, Marlborough, MA, USA) will perform at least 2 roll-in cases before commencing treatment in the randomized cohort. Centers with prior experience with ACURATE are not required to do roll-in cases. Data from roll-in subjects will be summarized separately from the randomized cohort and will not be included in the primary endpoint analysis.
  • 4D CT Imaging Substudy: Selected centers with the ability to perform high quality 4D computer tomography (CT) scans will include subjects in a 4D CT Imaging Substudy to assess the prevalence of reduced leaflet mobility and hypoattenuated leaflet thickening (HALT) and the relationship, if any, to clinical events. Subjects will be randomized to test (ACURATE) and control device.
  • ACURATE Prime™ XL Nested Registry: A non-randomized, nested registry cohort of subjects who will receive the ACURATE Prime™ Transfemoral Aortic Valve System XL (ACURATE Prime XL Nested Registry). Participating centers will be a subset of United States centers that have enrolled subjects in ACURATE IDE. Data from subjects in this nested registry will be summarized separately from the randomized and roll-in cohorts.
  • ACURATE Extended Durability Study: An additional 1:1 randomized study (ACURATE versus a commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration [SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA] or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration [CoreValve; Medtronic, Inc., Dublin, Ireland]) including only subjects considered to be at low surgical risk. Subjects will receive ACURATE neo2 (S, M, or L valve sizes) or ACURATE Prime XL. Data from subjects in the Extended Durability Study will be summarized separately from other cohorts.
  • ACURATE Continued Access Study (CAS): An additional cohort of subjects receiving ACURATE neo2 (S, M, and L valve sizes) or ACURATE Prime XL. Data from subjects in the ACURATE CAS will be summarized separately from other cohorts and will be used to further assess performance and safety.

All subjects implanted will be followed at baseline, peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and then annually for up to 10 years post-procedure. Enrolled subjects who do not have a study device implanted will be assessed through 1-year post-procedure for safety/adverse events.

Study Type

Interventional

Enrollment (Estimated)

2820

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
      • Québec, Canada, G1V 4G5
        • Active, not recruiting
        • Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3W5
        • Recruiting
        • Royal Columbian Hospital
        • Contact:
        • Principal Investigator:
          • Albert Chan, MD
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Recruiting
        • Providence Health - St. Paul's Hospital
        • Contact:
        • Principal Investigator:
          • John Webb, MD
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • Recruiting
        • London Health Sciences
        • Contact:
        • Principal Investigator:
          • Pantelis Diamantouros, MD
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Health Sciences Centre
        • Contact:
        • Principal Investigator:
          • Shaym Radhakrishnan, MD
    • Quebec
      • Montreal, Quebec, Canada, H2X 3E4
        • Recruiting
        • Centre Hospitalier de l'Universite de Montreal (CHUM)
        • Contact:
        • Principal Investigator:
          • Jeannot Potvin, MD
      • Montréal, Quebec, Canada, H1T 1C8
        • Withdrawn
        • Institut de Cardiologie de Montreal
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama at Birmingham
        • Contact:
        • Principal Investigator:
          • Mustafa Ahmed, MD
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Recruiting
        • Banner Good Samaritan
        • Principal Investigator:
          • Marvin Eng, MD
        • Contact:
      • Scottsdale, Arizona, United States, 85260
        • Recruiting
        • HonorHealth Scottsdale Healthcare
        • Principal Investigator:
          • David Rizik, MD
        • Contact:
      • Tucson, Arizona, United States, 85712
        • Recruiting
        • TMC Healthcare
        • Contact:
        • Principal Investigator:
          • Thomas Waggoner, MD
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • Baptist Health Medical Center
        • Principal Investigator:
          • Ernesto Ruiz-Rodriguez, MD
        • Contact:
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • Scripps Clinic
        • Contact:
        • Principal Investigator:
          • Paul Teirstein, MD
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Heart Institute
        • Contact:
        • Principal Investigator:
          • Raj R Makkar, MD
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Kaiser Permanente Los Angeles
        • Contact:
        • Principal Investigator:
          • Somjot Brar, MD
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California, Davis Medical Center
        • Contact:
        • Principal Investigator:
          • Jeffrey Southard, MD
      • San Francisco, California, United States, 94115
        • Recruiting
        • Kaiser Permanente - San Francisco
        • Contact:
        • Principal Investigator:
          • Andrew Rassi, MD
      • Stanford, California, United States, 94305
        • Active, not recruiting
        • Stanford University Medical Center
    • Colorado
      • Littleton, Colorado, United States, 80120
        • Withdrawn
        • South Denver Cardiology Associates PC
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • MedStar Washington Hospital Center
        • Contact:
        • Principal Investigator:
          • Lowell Satler, MD
    • Florida
      • Clearwater, Florida, United States, 33756
        • Recruiting
        • Morton Plant Hospital
        • Contact:
        • Principal Investigator:
          • Joshua D Rovin, MD
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Orlando Regional Medical Center
        • Contact:
        • Principal Investigator:
          • Vijaykumar Kasi, MD
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Recruiting
        • Piedmont Hospital
        • Principal Investigator:
          • Vivek Rajagopal, MD
        • Contact:
      • Atlanta, Georgia, United States, 30308
        • Withdrawn
        • Emory University Hospital (Midtown)
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Recruiting
        • NorthShore University Health Study Coordinator
        • Principal Investigator:
          • Justin Levisay, MD
        • Contact:
      • Oak Lawn, Illinois, United States, 60453
        • Recruiting
        • Advocate Christ Medical Center
        • Contact:
        • Principal Investigator:
          • Ravi Ramana, MD
      • Springfield, Illinois, United States, 62769
        • Active, not recruiting
        • St. John's Hospital (Prairie)
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • Active, not recruiting
        • St. Vincent's Hospital
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa
        • Contact:
        • Principal Investigator:
          • Phillip Horwitz, MD
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • Recruiting
        • Union Memorial Hospital
        • Contact:
        • Principal Investigator:
          • John Wang, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital
        • Contact:
        • Principal Investigator:
          • Ashraf Sabe, MD
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
        • Principal Investigator:
          • Ignacio Inglessis, MD
      • Worcester, Massachusetts, United States, 01655
        • Recruiting
        • University of Massachusetts
        • Contact:
        • Principal Investigator:
          • Nikos Kakouros, MD
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Contact:
        • Principal Investigator:
          • Stanley Chetcuti, MD
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
        • Contact:
        • Principal Investigator:
          • Pedro Engel Gonzalez, MD
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Abbott Northwestern Hospital
        • Principal Investigator:
          • Paul Sorajja, MD
        • Contact:
      • Saint Cloud, Minnesota, United States, 56303
        • Recruiting
        • CentraCare Heart and Vascular Center
        • Contact:
        • Principal Investigator:
          • Brian Stegman, MD
      • Saint Paul, Minnesota, United States, 55102
        • Recruiting
        • St. Joseph's Hospital-St. Paul
        • Contact:
        • Principal Investigator:
          • Marat Yanavitski, MD
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Withdrawn
        • Barnes Jewish Hospital
    • New Jersey
      • Browns Mills, New Jersey, United States, 08015
        • Active, not recruiting
        • Deborah Heart and Lung Center
      • Englewood, New Jersey, United States, 07631
        • Recruiting
        • Englewood Health
        • Contact:
        • Principal Investigator:
          • Joseph DeGregorio, MD
      • New Brunswick, New Jersey, United States, 08901
        • Active, not recruiting
        • Robert Wood Johnson Medical Center
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • Albany Medical Center
        • Principal Investigator:
          • Sanjay Samy, MD
        • Contact:
          • Sanjay Samy, MD
          • Phone Number: 518-262-9777
          • Email: samys@amc.edu
      • Bronx, New York, United States, 10461
        • Recruiting
        • Montefiore-Jack D. Weiler Hospital
        • Contact:
        • Principal Investigator:
          • Mohamed Azeem Latib, MD
      • Buffalo, New York, United States, 14203
        • Recruiting
        • Kaleida Health
        • Contact:
        • Principal Investigator:
          • Vijay Iyer, MD
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai Medical Center
        • Contact:
        • Principal Investigator:
          • Annapoorna Kini, MD
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center/NYPH
        • Contact:
        • Principal Investigator:
          • Tamim Nazif, MD
      • New York, New York, United States, 10065
        • Recruiting
        • Cornell Presbyterian - New York
        • Contact:
        • Principal Investigator:
          • Shing-Chiu Wong, MD
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • University of North Carolina
        • Principal Investigator:
          • John Vavalle, MD
        • Contact:
      • Charlotte, North Carolina, United States, 28203
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University School of Medicine
        • Principal Investigator:
          • David Zhao, MD
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • Lindner Center for Research and Education at Christ Hospital
        • Contact:
        • Principal Investigator:
          • Joseph Choo, MD
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
        • Principal Investigator:
          • Samir Kapadia, MD
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals of Cleveland
        • Contact:
        • Principal Investigator:
          • Guilherme Attizzani, MD
      • Columbus, Ohio, United States, 43213
        • Withdrawn
        • Mount Carmel Columbus Cardiology Consultants
      • Columbus, Ohio, United States, 43214
        • Recruiting
        • OhioHealth Research and Innovation Institute
        • Contact:
        • Principal Investigator:
          • Steven Yakubov, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Active, not recruiting
        • Integris Baptist Medical Center
    • Oregon
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence Heart Institute
        • Contact:
        • Principal Investigator:
          • Ethan Korngold, MD
      • Springfield, Oregon, United States, 97477
        • Recruiting
        • Sacred Heart Medical Center - Riverbend
        • Contact:
        • Principal Investigator:
          • Sudeshna Banerjee, MD
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17101
        • Recruiting
        • UPMC - Pinnacle
        • Contact:
        • Principal Investigator:
          • Hemal Gada, MD
      • Pittsburgh, Pennsylvania, United States, 15213
        • Completed
        • UPMC Pittsburgh
      • Wynnewood, Pennsylvania, United States, 19086
        • Recruiting
        • Lankenau
        • Contact:
        • Principal Investigator:
          • Eric Gnall, DO
      • York, Pennsylvania, United States, 17403
        • Recruiting
        • WellSpan York Hospital
        • Contact:
        • Principal Investigator:
          • James Harvey, MD
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Principal Investigator:
          • Daniel Steinberg, MD
        • Contact:
      • West Columbia, South Carolina, United States, 29169
        • Recruiting
        • Lexington Medical Center
        • Contact:
        • Principal Investigator:
          • Robert Leonardi
    • Tennessee
      • Nashville, Tennessee, United States, 37205
        • Recruiting
        • St Thomas Ascension
        • Contact:
        • Principal Investigator:
          • Michael A Morse, MD
    • Texas
      • Austin, Texas, United States, 78705
        • Recruiting
        • Austin Heart
        • Contact:
        • Principal Investigator:
          • Francis Zidar, MD
      • Dallas, Texas, United States, 75226
        • Recruiting
        • Baylor Heart and Vascular Hospital
        • Contact:
        • Principal Investigator:
          • Robert Stoler, MD
      • Dallas, Texas, United States, 75231
        • Recruiting
        • Presbyterian Hospital of Dallas
        • Principal Investigator:
          • James Park, MD
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas Health Science Center at Houston
        • Contact:
        • Principal Investigator:
          • Abhijeet Dhoble, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • The Methodist Hospital Research Institute
        • Contact:
        • Principal Investigator:
          • Neil Kleiman, MD
      • Plano, Texas, United States, 75093
        • Recruiting
        • Baylor Regional Medical Center at Plano
        • Principal Investigator:
          • Srinivasa Potluri, MD
        • Contact:
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Methodist Healthcare System of San Antonio dba Methodist Hospital
        • Contact:
        • Principal Investigator:
          • Jorge Alvarez, MD
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Recruiting
        • The University of Vermont Medical Center
        • Contact:
        • Principal Investigator:
          • Harold Dauerman, MD
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia Health System
        • Contact:
        • Principal Investigator:
          • Michael Ragosta, MD
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Sentara Norfolk General Hospital
        • Contact:
        • Principal Investigator:
          • Deepak Talreja, MD
    • Washington
      • Everett, Washington, United States, 98201
        • Active, not recruiting
        • Providence Regional Medical Center
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54301
        • Recruiting
        • Bellin Health
        • Contact:
        • Principal Investigator:
          • Jason Ricci, MD
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin - Froedtert Hospital
        • Contact:
        • Principal Investigator:
          • Panayotis Fasseas, MD
      • Milwaukee, Wisconsin, United States, 53024
        • Recruiting
        • Aurora Research Institute
        • Contact:
        • Principal Investigator:
          • Tanvir Bajwa, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • IC1. Subject has documented severe symptomatic native aortic stenosis defined as follows: aortic valve area (AVA) ≤1.0 cm2 (or AVA index ≤0.6 cm2/m2) AND a mean pressure gradient ≥40 mmHg, OR maximal aortic valve velocity ≥4.0 m/s, OR Doppler velocity index ≤0.25 as measured by echocardiography and/or invasive hemodynamics.

Note: In cases of low flow, low gradient aortic stenosis with left ventricular dysfunction (ejection fraction <50%), dobutamine can be used to assess the grade of aortic stenosis (maximum dobutamine dose of 20 mcg/kg/min recommended); the subject may be enrolled if echocardiographic criteria are met with this augmentation.

  • IC2. Subject has a documented aortic annulus size of ≥20.5 mm and ≤29 mm based on the center's assessment of pre-procedure diagnostic imaging (and confirmed by the Case Review Committee [CRC]) and, for the Main Randomized Cohort and the Extended Durability Study, is deemed treatable with an available size of both test and control device.
  • IC3. For subjects with symptomatic aortic valve stenosis per IC1 definition above, functional status is NYHA Functional Class ≥ II.
  • IC4. Heart team (which must include an experienced cardiac interventionalist and an experienced cardiac surgeon) agrees that the subject is indicated for TAVR, is likely to benefit from valve replacement, and TAVR is appropriate.
  • IC5. Subject (or legal representative) understands the study requirements and the treatment procedures, and provides written informed consent.
  • IC6. Subject, family member, and/or legal representative agree(s) and subject is capable of returning to the study hospital for all required scheduled follow up visits.
  • IC7. Subject is expected to be able to take the protocol-required adjunctive pharmacologic therapy.

Exclusion Criteria:

  • EC1. Subject has a unicuspid or bicuspid aortic valve.
  • EC2. Subject has had an acute myocardial infarction within 30 days prior to the index procedure (defined as Q-wave MI or non-Q-wave MI with total CK elevation ≥ twice normal in the presence of CK-MB elevation and/or troponin elevation).
  • EC3. Subject has had a cerebrovascular accident or transient ischemic attack clinically confirmed by a neurologist or neuroimaging within the past 6 months prior to study enrollment.
  • EC4. Subject is on renal replacement therapy or has eGFR <20.
  • EC5. Subject has a pre-existing prosthetic aortic or mitral valve.
  • EC6. Subject has severe (4+) aortic, tricuspid, or mitral regurgitation.
  • EC7. Subject has moderate or severe mitral stenosis (mitral valve area ≤1.5 cm2 and diastolic pressure half-time ≥150 ms, Stage C or D76).
  • EC8. Subject has a need for emergency surgery for any reason.
  • EC9. Subject has a history of endocarditis within 6 months of index procedure or evidence of an active systemic infection or sepsis.
  • EC10. Subject has echocardiographic evidence of new intra-cardiac vegetation or intraventricular or paravalvular thrombus requiring intervention.
  • EC11. Subject has platelet count <50,000 cells/mm3 or >700,000 cells/mm3, or white blood cell count <1,000 cells/mm3.
  • EC12. Subject has had a gastrointestinal bleed requiring hospitalization or transfusion within the past 3 months, or has other clinically significant bleeding diathesis or coagulopathy that would preclude treatment with required antiplatelet regimen, or will refuse transfusions.
  • EC13. Subject has known hypersensitivity to contrast agents that cannot be adequately pre-medicated, or has known hypersensitivity to the protocol required medications (aspirin, all P2Y12 inhibitors, heparin), or to the individual components of the test or control valve (nickel, titanium, stainless steel, platinum, iridium or polyethylene terephthalate [PET]).
  • EC14. Subject has a life expectancy of less than 12 months due to non-cardiac, comorbid conditions based on the assessment of the investigator at the time of enrollment.
  • EC15. Subject has hypertrophic cardiomyopathy.
  • EC16. Subject has any therapeutic invasive cardiac or vascular procedure within 30 days prior to the index procedure (except for balloon aortic valvuloplasty, pacemaker implantation, or implantable cardioverter defibrillator implantation, which are allowed).
  • EC17. Subject has untreated coronary artery disease, which in the opinion of the treating physician is clinically significant and requires revascularization.
  • EC18. Subject has severe left ventricular dysfunction with ejection fraction <20%.
  • EC19. Subject is in cardiogenic shock or has hemodynamic instability requiring inotropic support or mechanical support devices.
  • EC20. Subject has arterial access that is not acceptable for the study device (test or control) delivery systems as defined in the device (test or control) Directions For Use.

  • EC21. Subject has either of the following:

    • Severe vascular disease that would preclude safe access (e.g., aneurysm with thrombus that cannot be crossed safely; marked tortuosity; significant narrowing of the abdominal aorta; severe unfolding of the thoracic aorta; or thick, protruding, ulcerated atheroma in the aortic arch), OR
    • Severe/eccentric calcification of the aortic annulus that would prevent safe implantation of the TAVR prosthesis.
  • EC22. Subject has current problems with substance abuse (e.g., alcohol, etc.) that may interfere with the subject's participation in this study.
  • EC23. Subject is participating in another investigational drug or device study that has not reached its primary endpoint or subject intends to participate in another investigational device clinical trial within 12 months after index procedure.
  • EC24. Subject has untreated conduction system disorder (e.g., Type II second degree atrioventricular block) that in the opinion of the treating physician is clinically significant and requires a pacemaker implantation. Enrollment is permissible after permanent pacemaker implantation.
  • EC25. Subject has severe incapacitating dementia.

Additional exclusion criteria apply to subjects considered for enrollment in the CT Imaging Substudy as listed below.

  • AEC1. Subject has eGFR <30 mL/min (chronic kidney disease stage IV or stage V)
  • AEC2. Subject has atrial fibrillation that cannot be rate controlled to ventricular response rate < 60 bpm.
  • AEC3. Subject is expected to undergo chronic anticoagulation therapy after the index procedure.

Note: Subjects treated with short-term anticoagulation post procedure can be included in the CT Imaging Substudy; in these subjects the 30-day imaging will be performed 30 days after discontinuation of anticoagulation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ACURATE Valve - Single-arm Roll-in
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
Device: ACURATE neo2™ Transfemoral TAVR System
ACURATE neo2™ Transfemoral TAVR system: Support frame made of nitinol, supra-annular processed tri-leaflet porcine pericardial valve and an outer skirt to limit paravalvular regurgitation (manufactured by Boston Scientific Corporation, Marlborough, MA, USA).
Experimental: ACURATE Valve - Single-arm Prime XL

Patients assigned to this group will be implanted with ACURATE Prime™ transfemoral TAVR System XL.

*50 subjects will be enrolled in the Prime™ XL Nested Registry
Device: ACURATE Prime™ Transfemoral TAVR System XL
ACURATE Prime™ Transfemoral TAVR system: Support frame made of nitinol, supra-annular processed tri-leaflet porcine pericardial valve and an outer skirt to limit paravalvular regurgitation (manufactured by Boston Scientific Corporation, Marlborough, MA, USA).
Experimental: ACURATE Valve - Main Randomized

Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.

*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
Device: ACURATE neo2™ Transfemoral TAVR System
ACURATE neo2™ Transfemoral TAVR system: Support frame made of nitinol, supra-annular processed tri-leaflet porcine pericardial valve and an outer skirt to limit paravalvular regurgitation (manufactured by Boston Scientific Corporation, Marlborough, MA, USA).
Active Comparator: Commercial Valve - Main Randomized

Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System

Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.

*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.
Device: Medtronic CoreValve TAVR System
Medtronic CoreValve Evolut R or Evolut PRO Transcatheter Aortic Valve Replacement (TAVR) System (or any future Corevalve iterations): The support frame is manufactured from nitinol, which has multilevel, self-expanding properties and is radiopaque. The bioprosthesis is manufactured by suturing valve leaflets and a skirt from porcine pericardium into a tri-leaflet configuration (manufactured by Medtronic CoreValve LLC, Santa Ana, USA).
Device: Edwards SAPIEN 3 TAVR System
Edwards SAPIEN 3 TAVR system (or any future SAPIEN iterations): balloon-expandable transcatheter aortic bioprosthesis, support frame made of cobalt-chromium, three leaflets constructed of processed bovine pericardial tissue and an outer polyethylene terephthalate (PET) sealing cuff to mitigate paravalvular regurgitation (manufactured by Edwards Lifesciences, Inc., Irvine, California, USA)
Experimental: ACURATE Valve - Extended Durability Randomized
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System (S, M, L) or ACURATE Prime™ transfemoral TAVR System XL. Only low risk patients are enrolled in this group.
Device: ACURATE neo2™ Transfemoral TAVR System
ACURATE neo2™ Transfemoral TAVR system: Support frame made of nitinol, supra-annular processed tri-leaflet porcine pericardial valve and an outer skirt to limit paravalvular regurgitation (manufactured by Boston Scientific Corporation, Marlborough, MA, USA).
Device: ACURATE Prime™ Transfemoral TAVR System XL
ACURATE Prime™ Transfemoral TAVR system: Support frame made of nitinol, supra-annular processed tri-leaflet porcine pericardial valve and an outer skirt to limit paravalvular regurgitation (manufactured by Boston Scientific Corporation, Marlborough, MA, USA).
Active Comparator: Commercial Valve - Extended Durability Randomized

Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System

Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device. Only low risk patients are enrolled in this group.
Device: Medtronic CoreValve TAVR System
Medtronic CoreValve Evolut R or Evolut PRO Transcatheter Aortic Valve Replacement (TAVR) System (or any future Corevalve iterations): The support frame is manufactured from nitinol, which has multilevel, self-expanding properties and is radiopaque. The bioprosthesis is manufactured by suturing valve leaflets and a skirt from porcine pericardium into a tri-leaflet configuration (manufactured by Medtronic CoreValve LLC, Santa Ana, USA).
Device: Edwards SAPIEN 3 TAVR System
Edwards SAPIEN 3 TAVR system (or any future SAPIEN iterations): balloon-expandable transcatheter aortic bioprosthesis, support frame made of cobalt-chromium, three leaflets constructed of processed bovine pericardial tissue and an outer polyethylene terephthalate (PET) sealing cuff to mitigate paravalvular regurgitation (manufactured by Edwards Lifesciences, Inc., Irvine, California, USA)
Experimental: ACURATE Valve - Continued Access Study
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System (S, M, L) or ACURATE Prime™ transfemoral TAVR System XL.
Device: ACURATE neo2™ Transfemoral TAVR System
ACURATE neo2™ Transfemoral TAVR system: Support frame made of nitinol, supra-annular processed tri-leaflet porcine pericardial valve and an outer skirt to limit paravalvular regurgitation (manufactured by Boston Scientific Corporation, Marlborough, MA, USA).
Device: ACURATE Prime™ Transfemoral TAVR System XL
ACURATE Prime™ Transfemoral TAVR system: Support frame made of nitinol, supra-annular processed tri-leaflet porcine pericardial valve and an outer skirt to limit paravalvular regurgitation (manufactured by Boston Scientific Corporation, Marlborough, MA, USA).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite rate of all-cause mortality, all stroke, and rehospitalization at 1 year in the Main Randomized Cohort.
Time Frame: Participants will be followed for the duration of hospital stay, through 1 year
Primary Effectiveness Endpoint; A Clinical Events Committee (CEC), independent group of physician experts was used to evaluate all reported cases of death and stroke to determine whether they met the specific protocol definition of the event. It is the CEC adjudicated result that is used in the endpoint analysis.
Participants will be followed for the duration of hospital stay, through 1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality: all-cause, cardiovascular, and non-cardiovascular
Time Frame: Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years.
Safety endpoint adjudicated by an independent Clinical Events Committee (CEC)
Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years.
Stroke: disabling and non-disabling
Time Frame: Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years.
Safety endpoint adjudicated by an independent Clinical Events Committee (CEC)
Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years.
Myocardial infarction (MI): periprocedural (≤72 hours post index procedure) and spontaneous (>72 hours post index procedure)
Time Frame: Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years.
Safety endpoint adjudicated by an independent Clinical Events Committee (CEC)
Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years.
Bleeding: life-threatening (or disabling) and major
Time Frame: Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4 and 5 years.
Safety endpoint adjudicated by an independent Clinical Events Committee (CEC)
Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4 and 5 years.
Major vascular complications
Time Frame: Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4 and 5 years.
Safety endpoint adjudicated by an independent Clinical Events Committee (CEC)
Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4 and 5 years.
Number of participants with a repeat procedure for valve-related dysfunction (surgical or interventional therapy)
Time Frame: Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years.
Safety endpoint adjudicated by an independent Clinical Events Committee (CEC)
Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years.
Number of Participants with hospitalization for valve-related symptoms or worsening congestive heart failure (NYHA class III or IV)
Time Frame: Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years.
Safety endpoint adjudicated by an independent Clinical Events Committee (CEC)
Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years.
Number of participants with new permanent pacemaker implantation resulting from new or worsened conduction disturbances
Time Frame: Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years.
Safety endpoint adjudicated by an independent Clinical Events Committee (CEC)
Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years.
Number of participants with new onset of atrial fibrillation or atrial flutter
Time Frame: Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years.
Safety endpoint adjudicated by an independent Clinical Events Committee (CEC)
Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years.
Number of participants with Acute kidney injury (AKI; ≤7 days post index procedure): based on the AKIN System Stage 3 (including renal replacement therapy) or Stage 2
Time Frame: Participants will be followed for the duration of hospital stay, through 7 days post index procedure.
Safety endpoint adjudicated by an independent Clinical Events Committee (CEC)
Participants will be followed for the duration of hospital stay, through 7 days post index procedure.
Number of participants with Coronary obstruction: periprocedural
Time Frame: Participants will be followed through 72 hours post index procedure
Safety endpoint adjudicated by an independent Clinical Events Committee (CEC)
Participants will be followed through 72 hours post index procedure
Number of participants with Ventricular septal perforation
Time Frame: Participants will be followed through 72 hours post index procedure
Safety endpoint adjudicated by an independent Clinical Events Committee (CEC)
Participants will be followed through 72 hours post index procedure
Number of participants with Mitral apparatus damage: periprocedural
Time Frame: Participants will be followed through 72 hours post index procedure
Safety endpoint adjudicated by an independent Clinical Events Committee (CEC)
Participants will be followed through 72 hours post index procedure
Number of participants with Cardiac tamponade: periprocedural
Time Frame: Participants will be followed through 72 hours post index procedure
Safety endpoint adjudicated by an independent Clinical Events Committee (CEC)
Participants will be followed through 72 hours post index procedure
Number of participants with Valve migration
Time Frame: Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years.
Safety endpoint adjudicated by an independent Clinical Events Committee (CEC)
Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years.
Number of participants with Valve embolization
Time Frame: Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years.
Safety endpoint adjudicated by an independent Clinical Events Committee (CEC)
Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years.
Number of participants with Ectopic valve deployment
Time Frame: Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years.
Safety endpoint adjudicated by an independent Clinical Events Committee (CEC)
Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years.
Number of participants with Transcatheter aortic valve (TAV)-in-TAV deployment
Time Frame: Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years.
Safety endpoint adjudicated by an independent Clinical Events Committee (CEC)
Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years.
Number of participants with Prosthetic aortic valve thrombosis
Time Frame: Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years.
Safety endpoint adjudicated by an independent Clinical Events Committee (CEC)
Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years.
Number of participants with Prosthetic aortic valve endocarditis
Time Frame: Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years.
Safety endpoint adjudicated by an independent Clinical Events Committee (CEC)
Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years.
Number of participants with Successful vascular access, delivery and deployment of the study valve, and successful retrieval of the delivery system (site reported assessment)
Time Frame: Participants will be followed for the duration of their procedure, an expected average of 1 day (peri- and post-procedure)
Device Performance endpoint, as measured by site reported data
Participants will be followed for the duration of their procedure, an expected average of 1 day (peri- and post-procedure)
Grade of aortic valve regurgitation: paravalvular, central and combined (echocardiographic assessment)
Time Frame: Participants will be followed for the duration of their procedure, an expected average of 1 day (peri- and post-procedure)
Device Performance endpoint, as assessed by Echocardiographic Core Laboratory
Participants will be followed for the duration of their procedure, an expected average of 1 day (peri- and post-procedure)
Number of participants with Device Success
Time Frame: Participants will be followed for the duration of their procedure, an expected average of 1 day (post-procedure)
Absence of procedural mortality, correct positioning of a single transcatheter valve in the proper anatomical location, and intended performance of the study device (indexed effective orifice area [iEOA] >0.85 cm2/m2 for BMI <30 kg/cm2 and iEOA >0.70 cm2/m2 for BMI ≥30 kg/cm2 plus either a mean aortic valve gradient <20 mm Hg or a peak velocity < 3m/sec, and no moderate or severe prosthetic valve aortic regurgitation)
Participants will be followed for the duration of their procedure, an expected average of 1 day (post-procedure)
Prosthetic aortic valve performance; Effective Orifice Area (EOA
Time Frame: Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 7 and 10 years.
Effective Orifice Area (EOA), as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory
Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 7 and 10 years.
Prosthetic aortic valve performance; Mean Aortic Gradient
Time Frame: Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 7 and 10 years.
Mean aortic gradient as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory
Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 7 and 10 years.
Prosthetic aortic valve performance; Peak Aortic Gradient
Time Frame: Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 7 and 10 years.
Peak Aortic Gradient as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory
Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 7 and 10 years.
Prosthetic aortic valve performance; Peak Aortic Velocity
Time Frame: Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 7 and 10 years.
Peak Aortic Velocity as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory
Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 7 and 10 years.
Prosthetic aortic valve performance; Grade of Aortic Regurgitation
Time Frame: Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 7 and 10 years.
Grade of Aortic Regurgitation as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory
Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 7 and 10 years.
New York Heart Association (NYHA) Functional Status classification
Time Frame: Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 7 and 10 years.
Evaluated by New York Heart Association (NYHA) classification
Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 7 and 10 years.
Neurological status; National Institutes of Health Stroke Scale (NIHSS) Assessment
Time Frame: Participants will be followed at discharge and 1 year.
- National Institutes of Health Stroke Scale (NIHSS) at discharge and 1 year
Participants will be followed at discharge and 1 year.
Neurological status; Modified Rankin Scale (mRS) Assessment
Time Frame: Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4 and 5 years.
- Modified Rankin Scale (mRS) at discharge and all follow-up visits through 5 years
Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4 and 5 years.
Neurological status; Neurological physical exam assessment
Time Frame: Participants will be followed for the duration of the trial, through 10 years.
- Neurological physical exam in all subjects where stroke is suspected
Participants will be followed for the duration of the trial, through 10 years.
Health Status; Kansas City Cardiomyopathy Quality of Life questionnaire Assessment
Time Frame: Participants will be followed for the duration of hospital stay, through 30 days, 1 and 5 years.
Evaluated by Kansas City Cardiomyopathy Quality of Life questionnaire
Participants will be followed for the duration of hospital stay, through 30 days, 1 and 5 years.
Health Status; SF-12 Quality of Life questionnaire Assessment
Time Frame: Participants will be followed for the duration of hospital stay, through 30 days, 1 and 5 years.
Evaluated by SF-12 Quality of Life questionnaire
Participants will be followed for the duration of hospital stay, through 30 days, 1 and 5 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Principal Investigator: Raj R. Makkar, MD, Cedars-Sinai Heart Institute
  • Principal Investigator: Michael J. Reardon, MD, Methodist DeBakey Heart & Vascular Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2019

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

November 1, 2034

Study Registration Dates

First Submitted

November 6, 2018

First Submitted That Met QC Criteria

November 7, 2018

First Posted (Actual)

November 8, 2018

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2408

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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