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

NCT05932615 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: ABT-CIP-10487
• Study Type: interventional
• Target: 1,500
• Locations: 8 countries
• Sites: 84

Brief Summary

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.

Conditions

Aortic Valve Stenosis; Heart Valve Diseases; Aortic Valve Disease; Heart Disease Structural Disorder

Keywords

NAVITOR; Heart disease; Transcatheter aortic valve implantation (TAVI); Aortic stenosis; Cardiovascular diseases

Outcome Measures

Primary Outcomes (1)

• Composite of all-cause mortality or all stroke

  Number of patients that had any of the outcome events.

  At 12 months post-procedure

Study Arms (2)

Navitor Transcatheter Aortic Valve Implantation (TAVI) System

EXPERIMENTAL

TAVI with Abbott Navitor Transcatheter Aortic Valve Implantation (TAVI) System

Device: Navitor Transcatheter Aortic Valve Implantation (TAVI) System

Any Commercially Available Transcatheter Aortic Valve System (CAV)

ACTIVE COMPARATOR

TAVI with any FDA approved commercially available Transcatheter Aortic Valve System (CAV)

Device: Any Commercially Available Transcatheter Aortic Valve (CAV) System

Interventions

Navitor Transcatheter Aortic Valve Implantation (TAVI) System DEVICE

TAVI for relief of calcific aortic stenosis in patients with symptomatic heart disease who are at intermediate or low risk for open surgical therapy.

Navitor Transcatheter Aortic Valve Implantation (TAVI) System

Any Commercially Available Transcatheter Aortic Valve (CAV) System DEVICE

TAVI for relief of calcific aortic stenosis in patients with symptomatic heart disease who are at intermediate or low risk for open surgical therapy.

Any Commercially Available Transcatheter Aortic Valve System (CAV)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject who is deemed to be at intermediate or low risk for open surgical aortic valve replacement:
• Intermediate risk: estimated risk of overall surgical mortality ≥ 3% and \< 8% at 30 days
• 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
• New York Heart Association (NYHA) Functional Classification of II, III, or IV
• Degenerative aortic valve stenosis

You may not qualify if:

• In the opinion of the Investigator, life expectancy is less than 2 years
• 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
• Untreated clinically significant coronary artery disease requiring revascularization
• 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
• 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
• Active peptic ulcer or upper GI bleeding within 3 months prior to index procedure that would preclude anticoagulation
• Recent (within 6 months prior to index procedure date) cerebrovascular accident (CVA) or a transient ischemic attack (TIA)
• Renal insufficiency (creatinine \> 3.0 mg/dL or eGFR \< 30 ml/min/1.73m2) and/or end stage renal disease requiring chronic dialysis
• 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.)
• Significant frailty as determined by the heart team (after objective assessment of frailty parameters) that would indicate high or extreme surgical risk
• Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation 3-4+)
• Aortic valve is a unicuspid or bicuspid valve as verified by echocardiography or CT.
• Severe ventricular dysfunction with LVEF \< 30% as measured by resting echocardiogram
• Pre-existing prosthetic heart valve or other implant (such as prosthetic ring or transcatheter edge-to-edge repair (TEER) clip) in any valve position
• Severe circumferential mitral annular calcification (MAC) which is continuous with calcium in the left ventricular outflow tract (LVOT)

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (84)

University Hospital - Univ. of Alabama at Birmingham (UAB)

Birmingham, Alabama, 35233, United States

Location

St. Joseph's Hospital & Medical Center

Phoenix, Arizona, 85013, United States

Location

Tucson Medical Center

Tucson, Arizona, 85712, United States

Location

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

Kaiser Permanente Fontana Medical Center

Fontana, California, 92335, United States

Location

Southern California Permanente Medical Group - La Jolla

La Jolla, California, 92037, United States

Location

University of California at San Francisco

San Francisco, California, 94143, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Los Robles Regional Medical Center

Thousand Oaks, California, 91360, United States

Location

St. Joseph's Hospital & Medical Center

Denver, Colorado, 80218, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

HCA Florida - JFK Hospital

Atlantis, Florida, 33462, United States

Location

HCA Florida Largo Hospital

Largo, Florida, 33770, United States

Location

Baptist Hospital of Miami

Miami, Florida, 33176, United States

Location

HCA Florida Ocala Hospital

Ocala, Florida, 34471, United States

Location

AdventHealth Orlando

Orlando, Florida, 32825, United States

Location

Tallahassee Research Institute

Tallahassee, Florida, 32308, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

Location

The Queen's Medical Center

Honolulu, Hawaii, 96814, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Endeavor Health

Evanston, Illinois, 60201, United States

Location

Northwestern Memorial Hospital

Evanston, Illinois, 60201, United States

Location

Ascension St. Vincent

Indianapolis, Indiana, 46290, United States

Location

Via Christi Regional Medical Center - St. Francis Campus

Wichita, Kansas, 67226, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

MedStar Union Memorial Hospital

Baltimore, Maryland, 21218, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Massachusetts Medical Center

Worcester, Massachusetts, 01655, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Western Michigan Univ. Homer Stryker M.D. School of Medicine

Kalamazoo, Michigan, 49048, United States

Location

MyMichigan Medical Center Midland

Midland, Michigan, 48670, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Morristown Medical Center

Morristown, New Jersey, 07962, United States

Location

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States

Location

Presbyterian Hospital

Albuquerque, New Mexico, 87106, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Columbia University Medical Center/NYPH

New York, New York, 10032, United States

Location

Montefiore Medical Center - Moses Division

New York, New York, 10467, United States

Location

St. Francis Hospital

Roslyn, New York, 11576, United States

Location

Mission Health & Hospitals

Asheville, North Carolina, 28801, United States

Location

East Carolina Heart Institute

Greenville, North Carolina, 27834, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Ohio Health Research Institute

Columbus, Ohio, 43113, United States

Location

Hillcrest Medical Center

Tulsa, Oklahoma, 74104, United States

Location

Pinnacle Health System

Mechanicsburg, Pennsylvania, 17055, United States

Location

Allegheny General Hospital - ASRI

Pittsburgh, Pennsylvania, 15212, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Lankenau Institute for Medical Research

Wynnewood, Pennsylvania, 19096, United States

Location

North Central Heart

Sioux Falls, South Dakota, 57108, United States

Location

Baptist Memorial Hospital

Memphis, Tennessee, 38120, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Ascension Texas Cardiovascular

Austin, Texas, 78705, United States

Location

Austin Heart

Austin, Texas, 78756, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Houston Methodist

Houston, Texas, 77030, United States

Location

UTHealth Memorial Hermann

Houston, Texas, 77030, United States

Location

Baylor Scott & White - The Heart Hospital Plano

Plano, Texas, 75093, United States

Location

Intermountain Health St George Regional Hospital

St. George, Utah, 84790, United States

Location

University of Virginia Medical Center

Charlottesville, Virginia, 22908, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Aurora Medical Group

Milwaukee, Wisconsin, 53215, United States

Location

John Hunter Hospital

Newcastle, New South Wales, 2300, Australia

Location

Royal Adelaide Hospital

Adelaide, Saustrl, 5000, Australia

Location

Monash Health

Clayton, Victoria, 3168, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

St. Paul's Hospital

Vancouver, British Columbia, V6E 1M7, Canada

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Institut de Cardiologie de Montreal (Montreal Heart Inst.)

Montreal, Quebec, H1T 1C8, Canada

Location

The Royal Victoria Hospital

Montreal, Quebec, H4A3J1, Canada

Location

Saint John Regional Hospital - New Brunswick Heart Centre

Saint John, NB E2L 4L4, Canada

Location

Hopital Haut Leveque

Pessac, AQT, 33600, France

Location

CHU Rennes, Pontchaillou

Rennes, Brittan, 35033, France

Location

Clinique Pasteur Toulouse

Toulouse, Midpyre, 31076, France

Location

St.-Johannes Hospital

Dortmund, N. RHIN, 44137, Germany

Location

Shaare Zedek Medical Center

Jerusalem, Jeruslm, 9103102, Israel

Location

Universitair Medisch Centrum Groningen

Groningen, Grogen, 9713 GZ, Netherlands

Location

Basel University Hospital

Basel, Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Heart Valve Diseases; Aortic Valve Disease; Heart Diseases; Cardiovascular Diseases

Interventions

Transcatheter Aortic Valve Replacement; Drug Delivery Systems

Condition Hierarchy (Ancestors)

Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures; Drug Therapy; Therapeutics

Study Officials

• Haresh Sachanandani

  Abbott Structural Heart

  STUDY DIRECTOR

• Michael Reardon, MD

  The Methodist Hospital Research Institute

  STUDY CHAIR

• Azeem Azeem, MD

  Montefiore Medical Center

  STUDY CHAIR

• Bassem Chehab, MD

  Ascension Via Christi Hospitals

  PRINCIPAL INVESTIGATOR

• Ibrahim Sultan, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: July 6, 2023
• Study Start: March 15, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2036
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (67); CA (6); CH (1); DE (1); NL (1); AU (4); FR (3); IL (1)