TVMR With the Innovalve System Trial - TWIST-BE TWIST-PILOT-BE
Not Applicable
Withdrawn
- Conditions
- Mitral Valve Regurgitation (Degenerative or Functional)
- Registration Number
- NCT05263375
- Lead Sponsor
- Innovalve Bio Medical Ltd.
- Brief Summary
Study to evaluate the safety and performance of the Innovalve mitral valve replacement system
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Clinically significant, symptomatic mitral regurgitation
- High risk for open-heart surgery
- Meets anatomical criteria
Exclusion Criteria
- Unsuitable anatomy
- Patient is inoperable
- EF <30%
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Number of patients with implant or delivery related serious adverse events at 30 days 30 days Number of patients with implant or delivery related serious adverse events at 30 days
- Secondary Outcome Measures
Name Time Method