Status:
WITHDRAWN
TVMR With the Innovalve System Trial - TWIST-BE TWIST-PILOT-BE
Lead Sponsor:
Innovalve Bio Medical Ltd.
Conditions:
Mitral Valve Regurgitation (Degenerative or Functional)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Study to evaluate the safety and performance of the Innovalve mitral valve replacement system
Eligibility Criteria
Inclusion
- Clinically significant, symptomatic mitral regurgitation
- High risk for open-heart surgery
- Meets anatomical criteria
Exclusion
- Unsuitable anatomy
- Patient is inoperable
- EF \<30%
Key Trial Info
Start Date :
June 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05263375
Start Date
June 1 2023
End Date
June 1 2025
Last Update
July 19 2024
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