ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation
NCT ID: NCT05932615
Last Updated: 2025-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
1500 participants
INTERVENTIONAL
2024-03-15
2036-04-30
Brief Summary
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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.
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Detailed Description
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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 approxmatly1500 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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Navitor Transcatheter Aortic Valve Implantation (TAVI) System
TAVI with Abbott Navitor Transcatheter Aortic Valve Implantation (TAVI) System
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.
Any Commercially Available Transcatheter Aortic Valve System (CAV)
TAVI with any FDA approved commercially available Transcatheter Aortic Valve System (CAV)
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
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
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
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Barathi Sethuraman
Role: STUDY_DIRECTOR
Abbott Structural Heart
Michael Reardon, MD
Role: STUDY_CHAIR
The Methodist Hospital Research Institute
Azeem Azeem, MD
Role: STUDY_CHAIR
Montefiore Medical Center
Bassem Chehab, MD
Role: PRINCIPAL_INVESTIGATOR
Ascension Via Christi Hospitals Wichita, Inc.
Ibrahim Sultan, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Pittsburgh Medical Center
Locations
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St. Joseph's Hospital & Medical Center
Phoenix, 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
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Borgess Medical Center
Kalamazoo, Michigan, United States
MyMichigan Medical Center Midland
Midland, Michigan, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Morristown Medical Center
Morristown, New Jersey, United States
Presbyterian Hospital
Albuquerque, New Mexico, United States
Winthrop-University Hospital
Mineola, New York, United States
New York University Langone Medical Center - Tisch Hospital
New York, New York, 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
Mission Health & Hospitals
Asheville, North Carolina, United States
East Carolina Heart Institute
Greenville, North Carolina, United States
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
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Memorial Hermann Hospital
Houston, Texas, United States
The Methodist Hospital
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
Aurora Medical Group
Milwaukee, Wisconsin, United States
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
Countries
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Other Identifiers
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ABT-CIP-10487
Identifier Type: -
Identifier Source: org_study_id
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