IRB Study Number 23-932
Status Recruiting
Phase Not Applicable
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
ENVISION is a prospective, randomized controlled, multi-center clinical investigation at up to 80 sites in the United States (U.S.) and Canada. The objective of ENVISION is to evaluate the safety and effectiveness of the NavitorTM 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.
Inclusion Criteria
- Subject who is judged by a Heart Team, including a cardiac surgeon, to be appropriate for transcatheter heart valve intervention therapy, and is deemed to be at intermediate or low risk for open surgical aortic valve replacement
- New York Heart Association (NYHA) Functional Classification of II, III, or IV
- Able and willing to return for required follow-up visits and assessments
- Additional Inclusion Criteria will be assessed by study staff
Exclusion Criteria
- Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period
- Need for emergency surgery for any reason
- In the opinion of the Investigator, life expectancy is less than 2 years
- Additional Exclusion Criteria will be assessed by study staff
