ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation (ENVISION)

Evaluation of the Navitor Transcatheter Heart Valve in Low and Intermediate Risk Patients Who Have Severe, Symptomatic, Aortic Stenosis Requiring Aortic Valve Replacement

The objective of ENVISION is to evaluate the safety and effectiveness of the Navitor Transcatheter Aortic Valve Implantation (TAVI) System for treating patients with symptomatic, severe native aortic stenosis who are considered intermediate or low risk for surgical mortality.

The trial will also evaluate the safety and effectiveness of the Navitor TAVI System in a valve-in-valve (ViV) application in patients with symptomatic heart disease due to failure of a surgical or transcatheter bioprosthetic aortic valve who are at high or greater surgical risk.

In addition, the trial will assess the safety of the Navitor TAVI System for the treatment of symptomatic, severe native aortic stenosis in patients with bicuspid aortic valve anatomy, irrespective of surgical risk classification.

Study Overview

• Status: Enrolling by invitation
• Conditions: Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Heart Disease Structural Disorder
• Intervention / Treatment: Device: Navitor Transcatheter Aortic Valve Implantation (TAVI) System; Device: Any Commercially Available Transcatheter Aortic Valve (CAV) System

Detailed Description

ENVISION is a prospective, multi-center clinical investigation at up to 135 sites globally. The objective of this clinical investigation is to evaluate the safety and effectiveness of the Navitor TAVI System for treating patients with symptomatic, severe native aortic stenosis who are considered intermediate or low risk for surgical mortality. The trial will register subjects in three separate cohorts: (1) a pivotal randomized cohort, (2) a valve-in-valve (ViV) cohort and (3) a bicuspid cohort.

The objective of the pivotal randomized cohort is to evaluate the safety and effectiveness of the Navitor TAVI System for treating patients with symptomatic, severe native aortic stenosis who are considered intermediate or low risk for surgical mortality.

The Randomization Cohort will enroll approximately 1500 subjects and will be randomized between the Navitor TAVI Implantation System (test arm) and any commercially available transcatheter aortic valve system (CAV) (control arm) in a 1:1 ratio.

The ViV cohort will be conducted as a separate prospective, multicenter, open label, two-group registry within the ENVISION IDE trial. A total of 250 subjects deemed to be at high or greater risk for open surgical therapy will be enrolled concurrently across two separate groups: 125 subjects undergoing transcatheter Aortic Valve-in-Surgical Aortic Valve replacement (TAV-in-SAV) and 125 subjects undergoing Transcatheter Aortic Valve-in-Transcatheter Aortic Valve replacement (TAV-in-TAV).

The bicuspid cohort will be conducted as a separate, prospective multicenter, open label study within the ENVISION IDE trial. A total of 250 symptomatic, severe aortic stenosis subjects with bicuspid aortic valve anatomy who are deemed suitable for transcatheter aortic valve implantation with a Navitor valve will be enrolled.

• Study Type: Interventional
• Enrollment (Estimated): 1500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Newcastle, New South Wales, Australia, 2300
      • John Hunter Hospital
  • Saustrl
    • Adelaide, Saustrl, Australia, 5000
      • Royal Adelaide Hospital
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Monash Health
    • Melbourne, Victoria, Australia, 3004
      • The Alfred Hospital
• Canada
  • Saint John, Canada, NB E2L 4L4
    • Saint John Regional Hospital - New Brunswick Heart Centre
  • British Columbia
    • Vancouver, British Columbia, Canada, V6E 1M7
      • St. Paul's Hospital
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4W7
      • University of Ottawa Heart Institute
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michael's Hospital
  • Quebec
    • Montreal, Quebec, Canada, H1T 1C8
      • Institut de Cardiologie de Montreal (Montreal Heart Inst.)
    • Montreal, Quebec, Canada, H4A3J1
      • The Royal Victoria Hospital
• France
  • AQT
    • Pessac, AQT, France, 33600
      • Hôpital Haut Levêque
  • Brittan
    • Rennes, Brittan, France, 35033
      • CHU Rennes, Pontchaillou
  • Midpyre
    • Toulouse, Midpyre, France, 31076
      • Clinique Pasteur Toulouse
• Germany
  • N. RHIN
    • Dortmund, N. RHIN, Germany, 44137
      • St.-Johannes Hospital
• Israel
  • Jeruslm
    • Jerusalem, Jeruslm, Israel, 9103102
      • Shaare Zedek Medical Center
• Netherlands
  • Grogen
    • Groningen, Grogen, Netherlands, 9713 GZ
      • Universitair Medisch Centrum Groningen
• Switzerland
  • Basel
    • Basel, Basel, Switzerland, 4031
      • Basel University Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University Hospital - Univ. of Alabama at Birmingham (UAB)
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • St. Joseph's Hospital & Medical Center
    • Tucson, Arizona, United States, 85712
      • Tucson Medical Center
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Arkansas Heart Hospital
  • California
    • Fontana, California, United States, 92335
      • Kaiser Permanente Fontana Medical Center
    • La Jolla, California, United States, 92037
      • Southern California Permanente Medical Group - La Jolla
    • San Francisco, California, United States, 94143
      • University of California at San Francisco
    • Stanford, California, United States, 94305
      • Stanford University Medical Center
    • Thousand Oaks, California, United States, 91360
      • Los Robles Regional Medical Center
  • Colorado
    • Denver, Colorado, United States, 80218
      • St. Joseph's Hospital & Medical Center
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Washington Hospital Center
  • Florida
    • Atlantis, Florida, United States, 33462
      • HCA Florida - JFK Hospital
    • Largo, Florida, United States, 33770
      • HCA Florida Largo Hospital
    • Miami, Florida, United States, 33176
      • Baptist Hospital of Miami
    • Ocala, Florida, United States, 34471
      • HCA Florida Ocala Hospital
    • Orlando, Florida, United States, 32825
      • AdventHealth Orlando
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Research Institute
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Heart Institute
    • Gainesville, Georgia, United States, 30501
      • Northeast Georgia Medical Center
  • Hawaii
    • Honolulu, Hawaii, United States, 96814
      • The Queen's Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center
    • Evanston, Illinois, United States, 60201
      • Endeavor Health
    • Evanston, Illinois, United States, 60201
      • Northwestern Memorial Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • Ascension St. Vincent
  • Kansas
    • Wichita, Kansas, United States, 67226
      • Via Christi Regional Medical Center - St. Francis Campus
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • MedStar Union Memorial Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Kalamazoo, Michigan, United States, 49048
      • Western Michigan Univ. Homer Stryker M.D. School of Medicine
    • Midland, Michigan, United States, 48670
      • MyMichigan Medical Center Midland
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Saint Luke's Hospital of Kansas City
  • New Jersey
    • Morristown, New Jersey, United States, 07962
      • Morristown Medical Center
    • New Brunswick, New Jersey, United States, 08901
      • Robert Wood Johnson University Hospital
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Presbyterian Hospital
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Hospital
    • New York, New York, United States, 10032
      • Columbia University Medical Center/NYPH
    • New York, New York, United States, 10467
      • Montefiore Medical Center - Moses Division
    • Roslyn, New York, United States, 11576
      • St. Francis Hospital
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Mission Health & Hospitals
    • Greenville, North Carolina, United States, 27834
      • East Carolina Heart Institute
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Christ Hospital
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic
    • Columbus, Ohio, United States, 43113
      • Ohio Health Research Institute
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Hillcrest Medical Center
  • Pennsylvania
    • Mechanicsburg, Pennsylvania, United States, 17055
      • Pinnacle Health System
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh Medical Center
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital - ASRI
    • Wynnewood, Pennsylvania, United States, 19096
      • Lankenau Institute for Medical Research
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • North Central Heart
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Baptist Memorial Hospital
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Austin, Texas, United States, 78756
      • Austin Heart
    • Austin, Texas, United States, 78705
      • Ascension Texas Cardiovascular
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center
    • Houston, Texas, United States, 77030
      • Houston Methodist
    • Houston, Texas, United States, 77030
      • UTHealth Memorial Hermann
    • Plano, Texas, United States, 75093
      • Baylor Scott & White - The Heart Hospital Plano
  • Utah
    • St. George, Utah, United States, 84790
      • Intermountain Health St George Regional Hospital
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Medical Center
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora Medical Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

1. Subject who is deemed to be at intermediate or low risk for open surgical aortic valve replacement:

   1. Intermediate risk: estimated risk of overall surgical mortality ≥ 3% and < 8% at 30 days
   2. Low risk: estimated risk of overall surgical mortality < 3% at 30 days Estimated risk of overall surgical mortality includes consideration of the Society of Thoracic Surgeons (STS) risk score, overall clinical status, and other clinical co-morbidities unmeasured by the risk calculator
2. New York Heart Association (NYHA) Functional Classification of II, III, or IV
3. Degenerative aortic valve stenosis

Key Exclusion Criteria:

1. In the opinion of the Investigator, life expectancy is less than 2 years
2. Evidence of an acute myocardial infarction [defined as ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) with acute ischemia symptoms and troponin elevation] within 30 days prior to index procedure
3. Untreated clinically significant coronary artery disease requiring revascularization
4. Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior (except pacemaker or implantable cardioverter defibrillator (ICD) implant) to index procedure or planned within 30 days following the index procedure
5. Blood dyscrasias as defined: leukopenia (WBC < 3000 mm3), acute anemia (Hb < 9 g/dL), thrombocytopenia (platelet count < 50,000 cells/mm³); history of bleeding diathesis or coagulopathy
6. Active peptic ulcer or upper GI bleeding within 3 months prior to index procedure that would preclude anticoagulation
7. Recent (within 6 months prior to index procedure date) cerebrovascular accident (CVA) or a transient ischemic attack (TIA)
8. Renal insufficiency (creatinine > 3.0 mg/dL or eGFR < 30 ml/min/1.73m2) and/or end stage renal disease requiring chronic dialysis
9. Hostile chest or conditions or complications from prior surgery that would make the subject be considered high surgical risk (i.e., mediastinitis, radiation damage, abnormal chest wall, porcelain aorta, adhesion of aorta or internal mammary artery to sternum, etc.)
10. Significant frailty as determined by the heart team (after objective assessment of frailty parameters) that would indicate high or extreme surgical risk
11. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation 3-4+)
12. Aortic valve is a unicuspid or bicuspid valve as verified by echocardiography or CT.
13. Severe ventricular dysfunction with LVEF < 30% as measured by resting echocardiogram
14. Pre-existing prosthetic heart valve or other implant (such as prosthetic ring or transcatheter edge-to-edge repair (TEER) clip) in any valve position
15. Severe circumferential mitral annular calcification (MAC) which is continuous with calcium in the left ventricular outflow tract (LVOT)
16. Severe (greater than or equal to 3+) mitral regurgitation or severe mitral stenosis
17. Minimum access vessel diameter of < 5.0 mm for small FlexNav Delivery System and < 5.5 mm for large FlexNav Delivery System
18. Eccentricity ratio of the annulus < 0.73

Additional Exclusion Criteria for Pivotal Randomized Cohort

1. Hostile Chest or conditions or complications from prior surgery that would make the subject be considered high surgical risk
2. Significant frailty as determined by the heart team (after objective assessment of frailty parameters) that would indicate high or extreme surgical risk
3. Mixed aortic valve disease
4. Aortic valve is a unicuspid or bicuspid valve as verified by echocardiography or CT
5. Inadequate aortic valve calcification
6. Pre-existing prosthetic heart valve or other implant (such as prosthetic ring or transcatheter edge-to-edge repair (TEER) clip) in any valve position

Additional Exclusion Criteria for ViV Cohort

1. Failing valve has moderate or greater paravalvular regurgitation.
2. Known severe prosthesis-patient mismatch
3. Failing valve is unstable, rocking, or not structurally intact.
4. Patient has a pre-existing prosthetic heart valve or other implant (such a prosthetic ring with a rigid support structure or transcatheter edge-to-edge repair clip) in any valve position other than aortic.
5. Bioprosthetic valve diameter that would not accommodate implantation of the Navitor Valve.
6. Increased risk of coronary obstruction by prosthetic leaflets of the index valve

Additional Exclusion Criteria for bicuspid cohort

1. In the opinion of the Investigator life expectancy is less than 1 year
2. Inadequate or severe aortic valve calcification and/or anatomical features that would preclude safe delivery of the valve

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Navitor Transcatheter Aortic Valve Implantation (TAVI) System; TAVI with Abbott Navitor Transcatheter Aortic Valve Implantation (TAVI) System	Device: Navitor Transcatheter Aortic Valve Implantation (TAVI) System; TAVI for relief of calcific aortic stenosis in patients with symptomatic heart disease who are at intermediate or low risk for open surgical therapy.
Active Comparator: Any Commercially Available Transcatheter Aortic Valve System (CAV); TAVI with any FDA approved commercially available Transcatheter Aortic Valve System (CAV)	Device: Any Commercially Available Transcatheter Aortic Valve (CAV) System; TAVI for relief of calcific aortic stenosis in patients with symptomatic heart disease who are at intermediate or low risk for open surgical therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of all-cause mortality or all stroke	Number of patients that had any of the outcome events.	At 12 months post-procedure

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Chair: Michael Reardon, MD, The Methodist Hospital Research Institute; Study Chair: Azeem Azeem, MD, Montefiore Medical Center; Study Director: Haresh Sachanandani, Abbott Structural Heart; Principal Investigator: Bassem Chehab, MD, Ascension Via Christi Hospitals; Principal Investigator: Ibrahim Sultan, MD

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2036

Study Registration Dates

• First Submitted: June 27, 2023
• First Submitted That Met QC Criteria: July 5, 2023
• First Posted (Actual): July 6, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Cardiovascular diseases; Heart disease; Aortic stenosis; Transcatheter aortic valve implantation (TAVI); NAVITOR
• Additional Relevant MeSH Terms: Ventricular Outflow Obstruction; Aortic Valve Disease; Aortic Valve Stenosis; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Therapeutics; Surgical Procedures, Operative; Drug Therapy; Cardiovascular Surgical Procedures; Cardiac Surgical Procedures; Thoracic Surgical Procedures; Prosthesis Implantation; Heart Valve Prosthesis Implantation; Drug Delivery Systems; Transcatheter Aortic Valve Replacement
• Other Study ID Numbers: ABT-CIP-10487

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make IPD available to other researhers.

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