A Feasibility Study to Assess Safety and Efficacy of the Transapical and Transfemoral JenaValve Pericardial TAVR System in the Treatment of Patients with Symptomatic Severe Aortic Stenosis (AS) (CA-0001)/ Symptomatic Severe Aortic Regurgitation (AR) (CA-0002)
Completed
- Conditions
- leaking heart valvenarrow heart valve10046973
- Registration Number
- NL-OMON46960
- Lead Sponsor
- JenaValve Technology, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
Adult patients with symptomatic severe aortic stenosis or symptomatic severe aortic regurgitation who are at high risk for surgical aortic valve replacement
Exclusion Criteria
Congenital uni- or bicuspid aortic valve morphology, previous prosthetic aortic valve implant, mitral regurgitation greater than moderate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Thirty (30)-day post-index procedure all-cause mortality (adjudicated).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Study endpoints are defined according to the standardized endpoint definitions<br /><br>for transcatheter aortic valve implantation as outlined in The Valve Academic<br /><br>Research Consortium-2 consensus document (i.e. VARC-2).</p><br>