ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation
- Conditions
- Aortic Valve StenosisHeart Valve DiseasesAortic Valve DiseaseHeart Disease Structural Disorder
- Interventions
- Device: Navitor Transcatheter Aortic Valve Implantation (TAVI) SystemDevice: Any Commercially Available Transcatheter Aortic Valve (CAV) System
- Registration Number
- NCT05932615
- Lead Sponsor
- Abbott Medical Devices
- 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.
- Detailed Description
ENVISION is a prospective, randomized controlled, multi-center clinical investigation that will randomize approximately 1500 subjects at up to 95 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. Subjects in this clinical investigation 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 1500
-
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
Key
- 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)
- Severe (greater than or equal to 3+) mitral regurgitation or severe mitral stenosis
- Minimum access vessel diameter of < 5.0 mm for small FlexNav Delivery System and < 5.5 mm for large FlexNav Delivery System
- Eccentricity ratio of the annulus < 0.73
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Navitor Transcatheter Aortic Valve Implantation (TAVI) System Navitor Transcatheter Aortic Valve Implantation (TAVI) System TAVI with Abbott Navitor Transcatheter Aortic Valve Implantation (TAVI) System Any Commercially Available Transcatheter Aortic Valve System (CAV) Any Commercially Available Transcatheter Aortic Valve (CAV) System TAVI with any FDA approved commercially available Transcatheter Aortic Valve System (CAV)
- Primary Outcome Measures
Name Time Method Composite of all-cause mortality or all stroke At 12 months post-procedure Number of patients that had any of the outcome events.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (61)
St. Joseph's Hospital & Medical Center
🇺🇸Denver, Colorado, 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
Stanford University Medical Center
🇺🇸Stanford, California, United States
Los Robles Regional Medical Center
🇺🇸Thousand Oaks, California, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Largo Medical Center
🇺🇸Largo, Florida, United States
Baptist Hospital of Miami
🇺🇸Miami, 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
Advocate Christ Medical Center
🇺🇸Oak Lawn, Illinois, United States
St. Vincent Hospital
🇺🇸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
St. Luke's Hospital
🇺🇸Kansas City, Missouri, United States
Atlantic Health System - Morristown Memorial Hospital
🇺🇸Morristown, New Jersey, 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
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 at Dallas
🇺🇸Dallas, Texas, United States
Memorial Hermann Hospital
🇺🇸Houston, Texas, United States
The Methodist Hospital
🇺🇸Houston, Texas, United States
The Heart Hospital Baylor Plano
🇺🇸Plano, Texas, United States
Intermountain St. George Regional Hospital
🇺🇸Saint 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
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
🇨🇦Montréal, Quebec, Canada
The Royal Victoria Hospital
🇨🇦Montréal, Quebec, Canada
Foothills Medical Centre
🇨🇦Calgary, Canada
Saint John Regional Hospital - New Brunswick Heart Centre
🇨🇦Saint John, Canada