Actively Recruiting
EFS of the CardioMech MVRS
Led by CardioMech AS · Updated on 2026-02-10
25
Participants Needed
12
Research Sites
526 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Safety and performance evaluation of the CardioMech Mitral Valve Repair System (MVRS) in patients with degenerative mitral valve regurgitation.
CONDITIONS
Official Title
EFS of the CardioMech MVRS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eighteen (18) years of age or greater
- Moderate to severe (≥3+) or severe (≥4+) mitral valve regurgitation due to mitral valve prolapse or flail
- Intermediate or high surgical risk for mitral valve repair as assessed by the site's heart team
You will not qualify if you...
- 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 evidence of calcification in the grasping area preventing device deployment
- Complex mitral regurgitation mechanism such as leaflet perforation, severe leaflet calcifications, commissural extension or prolapse, multiple flail or prolapsing segments, or cleft
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Cardiovascular Institute of Los Robles Health System
Thousand Oaks, California, United States, 91360
Active, Not Recruiting
2
Northwestern University
Evanston, Illinois, United States, 60208
Actively Recruiting
3
Ascension St. Francis via Christi
Wichita, Kansas, United States, 67226
Actively Recruiting
4
Mayo Clinic
Rochester, Minnesota, United States, 55902
Actively Recruiting
5
CentraCare Heart & Vascular Center
Saint Cloud, Minnesota, United States, 56303
Actively Recruiting
6
NYU Langone
New York, New York, United States, 10016
Actively Recruiting
7
Atrium Health Sanger Heart and Vascular Institute
Charlotte, North Carolina, United States, 28204
Active, Not Recruiting
8
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Actively Recruiting
9
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
10
Ascension St. Thomas West
Nashville, Tennessee, United States, 37205
Actively Recruiting
11
Baylor Scott & White, The Heart Hospital
Plano, Texas, United States, 75093
Actively Recruiting
12
Intermountain Medical Center
Murray, Utah, United States, 84107
Actively Recruiting
Research Team
J
Jennifer Ruether
CONTACT
R
Rick Nehm
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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