Aortic Valve Disease, Aortic Valve Stenosis, Heart Disease Structural Disorder, Heart Valve Diseases
Conditions
Keywords
NAVITOR, Heart disease, Transcatheter aortic valve implantation (TAVI), Aortic stenosis, Cardiovascular diseases
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.
Detailed description
ENVISION is a prospective, multi-center clinical investigation at up to 135 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. The trial will register subjects in three separate cohorts: (1) a pivotal randomized cohort, (2) a valve-in-valve (ViV) cohort and (3) a bicuspid cohort. 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 approximately 1500 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). The bicuspid cohort will be conducted as a separate, prospective multicenter, open label study within the ENVISION IDE trial. A total of 250 symptomatic, severe aortic stenosis subjects with bicuspid aortic valve anatomy who are deemed suitable for transcatheter aortic valve implantation with a Navitor valve will be enrolled.
Interventions
DEVICENavitor 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.
DEVICEAny 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.
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of all-cause mortality or all stroke | At 12 months post-procedure | Number of patients that had any of the outcome events. |
Countries
Australia, Belgium, Canada, Denmark, France, Germany, Israel, Italy, Netherlands, Sweden, Switzerland, United Kingdom, United States
Contacts
STUDY_DIRECTORHaresh Sachanandani
Abbott Structural Heart
STUDY_CHAIRMichael Reardon, MD
The Methodist Hospital Research Institute
STUDY_CHAIRAzeem Azeem, MD
Montefiore Medical Center
PRINCIPAL_INVESTIGATORBassem Chehab, MD
Ascension Via Christi Hospitals Wichita
PRINCIPAL_INVESTIGATORIbrahim Sultan, MD
Outcome results
None listed