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

Study Overview
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Brief Summary
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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
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ENVISION is a prospective, randomized controlled, multi-center clinical investigation that will randomize up to 1300 subjects at up to 80 sites in the U.S. and Canada. 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.

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

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

Intervention / Treatment
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* Device: Navitor Transcatheter Aortic Valve Implantation (TAVI) System
* Device: Any Commercially Available Transcatheter Aortic Valve (CAV) System


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NAVITOR, Heart disease, Transcatheter aortic valve implantation (TAVI), Aortic stenosis, Cardiovascular diseases