NL-OMON46960
Completed
Not Applicable
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) - JenaValve AS/AR Feasibility Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- leaking heart valve
- Sponsor
- JenaValve Technology, Inc.
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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