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

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.

As of 28-May-2025, Boston Scientific Corporation (BSC) announced the voluntary global discontinuation of the ACURATE product platform, including both the ACURATE neo2 and ACURATE Prime Aortic Valve Systems. BSC will no longer pursue regulatory approval for the device in the U.S. or other unapproved geographies.

Study Overview

• Status: Active, not recruiting
• Conditions: Aortic Stenosis
• Intervention / Treatment: Device: ACURATE neo2™ Transfemoral TAVR System; Device: Medtronic CoreValve TAVR System; Device: Edwards SAPIEN 3 TAVR System; Device: ACURATE Prime™ Transfemoral TAVR System XL

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.

Follow-up

• Subjects implanted with a test device will be assessed at baseline, peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, 1 year, and then annually for 5 years post-procedure.
• Subjects implanted with a control device will be assessed at baseline, peri- and post-procedure, at discharge or 7 days post procedure (whichever comes first), 30 days, 6 months, and 1 year post procedure. Per protocol, no additional follow-up is required beyond this period, and standard of care practices will apply.
• Some subjects may have completed additional annual follow-up visits based on requirements outlined in earlier versions of the protocol.
• Subjects who are enrolled but not implanted with a test or control device at the time of the procedure will be followed for safety through 1 year.

• Study Type: Interventional
• Enrollment (Actual): 1948
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • New Westminster, British Columbia, Canada, V3L 3W5
      • Royal Columbian Hospital
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • Providence Health - St. Paul's Hospital
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre
  • Quebec
    • Montreal, Quebec, Canada, H2X 3E4
      • Centre hospitalier de l'Université de Montréal (CHUM)
    • Québec, Quebec, Canada, G1V 4G5
      • Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Banner Good Samaritan
    • Scottsdale, Arizona, United States, 85260
      • HonorHealth Scottsdale Healthcare
    • Tucson, Arizona, United States, 85712
      • TMC HealthCare
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Baptist Health Medical Center
  • California
    • La Jolla, California, United States, 92037
      • Scripps Clinic
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Heart Institute
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente Los Angeles
    • Sacramento, California, United States, 95817
      • University of California, Davis Medical Center
    • San Francisco, California, United States, 94115
      • Kaiser Permanente - San Francisco
    • Stanford, California, United States, 94305
      • Stanford University Medical Center
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Medstar Washington Hospital Center
  • Florida
    • Clearwater, Florida, United States, 33756
      • Morton Plant Hospital
    • Orlando, Florida, United States, 32806
      • Orlando Regional Medical Center
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Hospital
  • Illinois
    • Glenview, Illinois, United States, 60026
      • Endeavor Glenbrook Hospital
    • Oak Lawn, Illinois, United States, 60453
      • Advocate Christ Medical Center
    • Springfield, Illinois, United States, 62769
      • St. John's Hospital (Prairie)
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • St. Vincent's Hospital
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • Union Memorial Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Abbott Northwestern Hospital
    • Saint Cloud, Minnesota, United States, 56303
      • CentraCare Heart and Vascular Center
    • Saint Paul, Minnesota, United States, 55102
      • St. Joseph's Hospital-St. Paul
  • New Jersey
    • Browns Mills, New Jersey, United States, 08015
      • Deborah Heart and Lung Center
    • Englewood, New Jersey, United States, 07631
      • Englewood Health
    • New Brunswick, New Jersey, United States, 08901
      • Robert Wood Johnson Medical Center
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical Center
    • Buffalo, New York, United States, 14203
      • Kaleida Health
    • New York, New York, United States, 10029
      • Mount Sinai Medical Center
    • New York, New York, United States, 10032
      • Columbia University Medical Center/NYPH
    • New York, New York, United States, 10065
      • Cornell Presbyterian - New York
    • The Bronx, New York, United States, 10461
      • Montefiore-Jack D. Weiler Hospital
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University School of Medicine
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Lindner Center for Research and Education at Christ Hospital
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Cleveland, Ohio, United States, 44106
      • University Hospitals of Cleveland
    • Columbus, Ohio, United States, 43214
      • OhioHealth Research and Innovation Institute
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • INTEGRIS Baptist Medical Center
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence Heart Institute
    • Springfield, Oregon, United States, 97477
      • Sacred Heart Medical Center - Riverbend
  • Pennsylvania
    • Harrisburg, Pennsylvania, United States, 17101
      • UPMC - Pinnacle
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Pittsburgh
    • Wynnewood, Pennsylvania, United States, 19086
      • Lankenau
    • York, Pennsylvania, United States, 17403
      • Wellspan York Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • West Columbia, South Carolina, United States, 29169
      • Lexington Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37205
      • St Thomas Ascension
  • Texas
    • Austin, Texas, United States, 78705
      • Austin Heart
    • Dallas, Texas, United States, 75226
      • Baylor Heart and Vascular Hospital
    • Dallas, Texas, United States, 75231
      • Presbyterian Hospital of Dallas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston
    • Houston, Texas, United States, 77030
      • The Methodist Hospital Research Institute
    • Plano, Texas, United States, 75093
      • Baylor Regional Medical Center at Plano
    • San Antonio, Texas, United States, 78229
      • Methodist Healthcare System of San Antonio dba Methodist Hospital
  • Vermont
    • Burlington, Vermont, United States, 05401
      • The University of Vermont Medical Center
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Health System
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital
  • Washington
    • Everett, Washington, United States, 98201
      • Providence Regional Medical Center
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54301
      • Bellin Health
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin - Froedtert Hospital
    • Milwaukee, Wisconsin, United States, 53024
      • Aurora Research Institute

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

7

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.	Primary Endpoint: A Clinical Events Committee (CEC), independent group of physician experts reviewed and adjudicated all reported cases of death, stroke and rehospitalization to determine whether they met the specific protocol definition of the event. The CEC adjudicated results are used in the endpoint analysis. * Hospitalization for valve-related symptoms or worsening congestive heart failure (NYHA class III or IV); per VARC-2 definition.	Participants will be followed for the duration of hospital stay through 1 year.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular	Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definition.	Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.
Rate of All Stroke: Disabling and Non-disabling	Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definition.	Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.
Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure)	Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.	Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.
Rate of Bleeding: Life-threatening (or Disabling) and Major	Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.	Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-5 years will be posted once data is complete.
Rate of Major Vascular Complications	Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.	Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-5 years will be posted once data is complete.
Rate of Repeat Procedure for Valve-related Dysfunction (Surgical or Interventional Therapy)	Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.	Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.
Rate of Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure (NYHA Class III or IV)	Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.	Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.
Rate of New Permanent Pacemaker Implantation (PPI) Resulting From New or Worsened Conduction Disturbances	Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.	Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.
Rate of New Onset of Atrial Fibrillation or Atrial Flutter	Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.	Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.
Rate of Acute Kidney Injury (AKI; ≤7 Days Post Index Procedure): Based on the AKIN System Stage 3 (Including Renal Replacement Therapy) or Stage 2	Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.	Participants will be followed peri- and post-procedure, through 7 days post index procedure.
Rate of Coronary Obstruction: Periprocedural	Safety outcome adjudicated by an independent Clinical Events Committee (CEC) - based on VARC endpoints and definitions.	Participants will be followed through 72 hours post index procedure
Rate of Ventricular Septal Perforation: Periprocedural	Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.	Participants will be followed through 72 hours post index procedure
Rate of Mitral Apparatus Damage: Periprocedural	Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.	Participants will be followed through 72 hours post index procedure
Rate of Cardiac Tamponade: Periprocedural	Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.	Participants will be followed through 72 hours post index procedure
Rate of Valve Migration	Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.	Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.
Rate of Valve Embolization	Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.	Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.
Rate of Ectopic Valve Deployment	Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.	Participants will be followed peri- and post-procedure through discharge or 7 days post-procedure (whichever comes first).
Rate of Transcatheter Aortic Valve (TAV)-In-TAV Deployment	Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.	Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.
Rate of Prosthetic Aortic Valve Thrombosis	Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.	Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.
Rate of Prosthetic Aortic Valve Endocarditis	Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.	Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.
Rate of Successful Vascular Access, Delivery and Deployment of the Study Valve, and Successful Retrieval of the Delivery System (Site Reported Assessment)	Device Performance outcome, as measured by site reported data based on VARC-2 endpoints and definitions.	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)	Grade of Aortic Regurgitation as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory.	Participants will be assessed pre-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-5 years, 7 years, and 10 years will be posted once data is complete.
Rate of Device Success	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 mmHg or a peak velocity < 3m, and no moderate or severe prosthetic valve aortic regurgitation) based on VARC-2 endpoints and definitions.	Participants will be followed for the duration of their procedure, an expected average of 1 Day (post-procedure)
Effective Orifice Area (EOA)	Effective Orifice Area (EOA), as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory	Participants will be assessed pre-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-5 years, 7 years, and 10 years will be posted once data is complete.
Mean Aortic Gradient	Mean Aortic Gradient as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory.	Participants will be assessed pre-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-5 years, 7 years, and 10 years will be posted once data is complete.
New York Heart Association (NYHA) Functional Status Classification	Health status evaluated by New York Heart Association (NYHA) Classification. NYHA Classification: Class I: Subjects with cardiac disease but without resulting limitations of physical activity. Class I: Subjects with cardiac disease resulting in slight limitation of physical activity. Class III: Subjects with cardiac disease resulting in marked limitation of physical activity. Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.	Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-5 years, 7 years, and 10 years will be posted once data is complete.
Health Status: Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life Assessment - Change From Baseline	Health Status additional outcome KCCQ Analysis - Overall Summary Score change from Baseline. Kansas City Cardiomyopathy Questionnaire (KCCQ): Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. Overall Summary Score - mean of score 1, 5, 7, and 8	Participants will be assessed at baseline, 30 Days, and 1 Year. Data for 5 years will be posted once data is complete.
Health Status: SF-12 Quality of Life Questionnaire Assessment - Change From Baseline	Health Status outcome - SF-12 - Baseline scores and changes from Baseline at 30 Days and 1 Year. 12 Item Short Form Health Survey (SF-12): Measures functional health and well-being. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.	Participants will be assessed at baseline, 30 Days, and 1 Year. Data for 5 years will be posted once data is complete.

Collaborators and Investigators

• 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

Publications and helpful links

General Publications

• Makkar RR, Chakravarty T, Gupta A, Soliman O, Gnall E, Ramana RK, Ramlawi B, Diamantouros P, Potluri S, Kleiman NS, Samy S, Rassi A, Yadav P, Thourani V, Yakubov S, Frawley C, Patel D, Kapadia S, Chalekian A, Modolo R, Sathananthan J, Kim WK, Reardon MJ. Valve Underexpansion and Clinical Outcomes With ACURATE neo2: Findings From the ACURATE IDE Trial. J Am Coll Cardiol. 2025 Jul 29;86(4):225-238. doi: 10.1016/j.jacc.2025.05.011. Epub 2025 May 21.
• Makkar RR, Ramana RK, Gnall E, Ramlawi B, Cheng W, Diamantouros P, Potluri S, Kleinman N, Gupta A, Chakravarty T, Samy S, Rassi A, Rajagopal V, Yakubov S, Sorajja P, Patel D, Garcia S, Yadav P, Thourani V, Wang J, Rinaldi M, Kapadia S, Waksman R, Webb J, Ren CB, Gregson J, Modolo R, Sathananthan J, Reardon MJ; ACURATE IDE study investigators. ACURATE neo2 valve versus commercially available transcatheter heart valves in patients with severe aortic stenosis (ACURATE IDE): a multicentre, randomised, controlled, non-inferiority trial. Lancet. 2025 Jun 7;405(10494):2061-2074. doi: 10.1016/S0140-6736(25)00319-8. Epub 2025 May 21.

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2019
• Primary Completion (Actual): June 14, 2024
• Study Completion (Estimated): September 1, 2029

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): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: S2408 (CTEP)

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
• product manufactured in and exported from the U.S.: No