EFS of the CardioMech MVRS
Recruiting
N/A
Interventional Study
Mitral Regurgitation
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
- Device Feasibility
- Participants needed
- 25 (estimated)
- Sponsor
- CardioMech AS · Industry
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About This Trial
Safety and performance evaluation of the CardioMech Mitral Valve Repair System (MVRS) in patients with degenerative mitral valve regurgitation.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Eighteen (18) years of age or greater
* Moderate to severe (≥3+) or severe (≥4+) mitral valve regurgitation (per American Society of Echocardiography (ASE) guidelines) due to mitral valve prolapse or flail
* Intermediate or high surgical risk for mitral valve repair
Exclusion…
Contacts