TVMR With the INNOVALVE System Trial - Early Feasibility Study
Recruiting
N/A
Interventional Study
Mitral Valve Regurgitation (Degenerative or Functional)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 65 (estimated)
- Sponsor
- Edwards Lifesciences · Industry
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About This Trial
Study to evaluate the safety and performance of the INNOVALVE system
Trial Locations
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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
* EF\<25%
Contacts