EFS of the CardioMech MVRS
- Conditions
- Mitral Regurgitation
- Registration Number
- NCT04820764
- Lead Sponsor
- CardioMech AS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria:<br><br> - Eighteen (18) years of age or greater<br><br> - Moderate to severe (=3+) or severe (=4+) mitral valve regurgitation (per American<br> Society of Echocardiography (ASE) guidelines) due to mitral valve prolapse or flail<br><br> - Intermediate or high surgical risk for mitral valve repair<br><br>Exclusion Criteria:<br><br> - History of rheumatic heart disease<br><br> - History of prior endocarditis<br><br> - History of prior repair or replacement of the mitral valve, annuloplasty or<br> valvuloplasty or has a left atrial appendage closure device<br><br> - Severely calcified mitral leaflet or has evidence of calcification in the grasping<br> area of the leaflets that would prevent leaflet anchor positioning and deployment<br><br> - Complex mechanism of MR (leaflet perforation, severe leaflet calcifications,<br> commissural extension, commissural prolapse, multiple flail or prolapsing segments,<br> cleft) present on required imaging
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Freedom from serious adverse events determined to be related to the CardioMech MVRS device or procedure;Change in MR grade
- Secondary Outcome Measures
Name Time Method