Early Feasibility Study of the CardioMech Mitral Valve Repair System (MVRS)
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Safety and performance evaluation of the CardioMech Mitral Valve Repair System (MVRS) in patients with degenerative mitral valve regurgitation.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Cardiovascular Institute of Los Robles Health System
ACTIVE_NOT_RECRUITING
Thousand Oaks
Illinois
Northwestern University
RECRUITING
Evanston
Kansas
Ascension St. Francis via Christi
RECRUITING
Wichita
Minnesota
Mayo Clinic
RECRUITING
Rochester
CentraCare Heart & Vascular Center
RECRUITING
Saint Cloud
North Carolina
Atrium Health Sanger Heart and Vascular Institute
ACTIVE_NOT_RECRUITING
Charlotte
New York
NYU Langone
RECRUITING
New York
Ohio
The Christ Hospital
RECRUITING
Cincinnati
Cleveland Clinic
RECRUITING
Cleveland
Tennessee
Ascension St. Thomas West
RECRUITING
Nashville
Texas
Baylor Scott & White, The Heart Hospital
RECRUITING
Plano
Utah
Intermountain Medical Center
RECRUITING
Murray
Contact Information
Primary
Jennifer Ruether
jennifer.ruether@cardiomech.com
651-248-4440
Backup
Rick Nehm
rick.nehm@cardiomech.com
Time Frame
Start Date: 2021-07-27
Estimated Completion Date: 2031-09
Participants
Target number of participants: 25
Treatments
Experimental: CardioMech Mitral Valve Repair System (MVRS)
Authors
Related Therapeutic Areas
Sponsors
Leads: CardioMech AS