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ENROLLING BY INVITATION

NCT05932615

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

Sponsor: Abbott Medical Devices

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1500

Start Date

2024-03-15

Completion Date

2036-04

Last Updated

2026-05-08

Healthy Volunteers

Conditions

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

Interventions

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.

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.

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

Locations (84)

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

Birmingham, Alabama, United States

St. Joseph's Hospital & Medical Center

Phoenix, Arizona, United States

Tucson Medical Center

Tucson, Arizona, United States

Arkansas Heart Hospital

Little Rock, Arkansas, United States

Kaiser Permanente Fontana Medical Center

Fontana, California, United States

Southern California Permanente Medical Group - La Jolla

La Jolla, California, United States

University of California at San Francisco

San Francisco, California, United States

Stanford University Medical Center

Stanford, California, United States

Los Robles Regional Medical Center

Thousand Oaks, California, United States

St. Joseph's Hospital & Medical Center

Denver, Colorado, United States

Washington Hospital Center

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

HCA Florida - JFK Hospital

Atlantis, Florida, United States

HCA Florida Largo Hospital

Largo, Florida, United States

Baptist Hospital of Miami

Miami, Florida, United States

HCA Florida Ocala Hospital

Ocala, Florida, United States

AdventHealth Orlando

Orlando, Florida, United States

Tallahassee Research Institute

Tallahassee, Florida, United States

Piedmont Heart Institute

Atlanta, Georgia, United States

Northeast Georgia Medical Center

Gainesville, Georgia, United States

The Queen's Medical Center

Honolulu, Hawaii, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Endeavor Health

Evanston, Illinois, United States

Northwestern Memorial Hospital

Evanston, Illinois, United States

Ascension St. Vincent

Indianapolis, Indiana, United States

Via Christi Regional Medical Center - St. Francis Campus

Wichita, Kansas, United States

Ochsner Medical Center

New Orleans, Louisiana, United States

MedStar Union Memorial Hospital

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Massachusetts Medical Center

Worcester, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

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

Kalamazoo, Michigan, United States

MyMichigan Medical Center Midland

Midland, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Morristown Medical Center

Morristown, New Jersey, United States

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States

Presbyterian Hospital

Albuquerque, New Mexico, United States

Mount Sinai Hospital

New York, New York, United States

Columbia University Medical Center/NYPH

New York, New York, United States

Montefiore Medical Center - Moses Division

New York, New York, United States

St. Francis Hospital

Roslyn, New York, United States

Mission Health & Hospitals

Asheville, North Carolina, United States

East Carolina Heart Institute

Greenville, North Carolina, United States

The Christ Hospital

Cincinnati, Ohio, United States

The Cleveland Clinic

Cleveland, Ohio, United States

Ohio Health Research Institute

Columbus, Ohio, United States

Hillcrest Medical Center

Tulsa, Oklahoma, United States

Pinnacle Health System

Mechanicsburg, Pennsylvania, United States

Allegheny General Hospital - ASRI

Pittsburgh, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Lankenau Institute for Medical Research

Wynnewood, Pennsylvania, United States

North Central Heart

Sioux Falls, South Dakota, United States

Baptist Memorial Hospital

Memphis, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Ascension Texas Cardiovascular

Austin, Texas, United States

Austin Heart

Austin, Texas, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Houston Methodist

Houston, Texas, United States

UTHealth Memorial Hermann

Houston, Texas, United States

Baylor Scott & White - The Heart Hospital Plano

Plano, Texas, United States

Intermountain Health St George Regional Hospital

St. George, Utah, United States

University of Virginia Medical Center

Charlottesville, Virginia, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Swedish Medical Center

Seattle, Washington, United States

West Virginia University

Morgantown, West Virginia, United States

Aurora Medical Group

Milwaukee, Wisconsin, United States

John Hunter Hospital

Newcastle, New South Wales, Australia

Royal Adelaide Hospital

Adelaide, Saustrl, Australia

Monash Health

Clayton, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

St. Paul's Hospital

Vancouver, British Columbia, Canada

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

Institut de Cardiologie de Montreal (Montreal Heart Inst.)

Montreal, Quebec, Canada

The Royal Victoria Hospital

Montreal, Quebec, Canada

Saint John Regional Hospital - New Brunswick Heart Centre

Saint John, Canada

Hopital Haut Leveque

Pessac, AQT, France

CHU Rennes, Pontchaillou

Rennes, Brittan, France

Clinique Pasteur Toulouse

Toulouse, Midpyre, France

St.-Johannes Hospital

Dortmund, N. RHIN, Germany

Shaare Zedek Medical Center

Jerusalem, Jeruslm, Israel

Universitair Medisch Centrum Groningen

Groningen, Grogen, Netherlands

Basel University Hospital

Basel, Basel, Switzerland

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (84)