Status:
SUSPENDED
EFS of the CardioMech MVRS
Lead Sponsor:
CardioMech AS
Conditions:
Mitral Regurgitation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Safety and performance evaluation of the CardioMech Mitral Valve Repair System (MVRS) in patients with degenerative mitral valve regurgitation.
Detailed Description
The purpose of the clinical study is to obtain clinical data on the CardioMech Mitral Valve Repair System (MVRS) in patients diagnosed with moderate to severe (≥3+) or severe (≥4+), symptomatic, degen...
Eligibility Criteria
Inclusion
- 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
- History of rheumatic heart disease
- History of prior endocarditis
- History of prior repair or replacement of the mitral valve, or annuloplasty
- Severely calcified mitral leaflet or has evidence of calcification in the grasping area of the leaflets that would prevent leaflet anchor positioning and deployment
- Complex mechanism of MR (leaflet perforation, severe leaflet calcifications, commissural extension, commissural prolapse, multiple flail or prolapsing segments, cleft) present on required imaging
Key Trial Info
Start Date :
July 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2031
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04820764
Start Date
July 27 2021
End Date
September 1 2031
Last Update
July 14 2025
Active Locations (9)
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1
Cardiovascular Institute of Los Robles Health System
Thousand Oaks, California, United States, 91360
2
Ascension St. Francis via Christi
Wichita, Kansas, United States, 67226
3
Mayo Clinic
Rochester, Minnesota, United States, 55902
4
CentraCare Heart & Vascular Center
Saint Cloud, Minnesota, United States, 56303