NCT05263375
Withdrawn
Not Applicable
TVMR With the Innovalve System Trial - Pilot Study in Belgium
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mitral Valve Regurgitation (Degenerative or Functional)
- Sponsor
- Innovalve Bio Medical Ltd.
- Primary Endpoint
- Number of patients with implant or delivery related serious adverse events at 30 days
- Status
- Withdrawn
- Last Updated
- last year
Overview
Brief Summary
Study to evaluate the safety and performance of the Innovalve mitral valve replacement system
Investigators
Eligibility Criteria
Inclusion Criteria
- •Clinically significant, symptomatic mitral regurgitation
- •High risk for open-heart surgery
- •Meets anatomical criteria
Exclusion Criteria
- •Unsuitable anatomy
- •Patient is inoperable
Outcomes
Primary Outcomes
Number of patients with implant or delivery related serious adverse events at 30 days
Time Frame: 30 days
Number of patients with implant or delivery related serious adverse events at 30 days
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