EFS of the CardioMech MVRS
Early Feasibility Study of the CardioMech Mitral Valve Repair System (MVRS)
1 other identifier
interventional
25
1 country
12
Brief Summary
Safety and performance evaluation of the CardioMech Mitral Valve Repair System (MVRS) in patients with degenerative mitral valve regurgitation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2021
Longer than P75 for not_applicable
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2021
CompletedFirst Posted
Study publicly available on registry
March 29, 2021
CompletedStudy Start
First participant enrolled
July 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2031
February 10, 2026
January 1, 2026
5.1 years
March 25, 2021
February 6, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Freedom from serious adverse events determined to be related to the CardioMech MVRS device or procedure
30 days
Change in MR grade
30 days
Study Arms (1)
CardioMech Mitral Valve Repair System (MVRS)
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CardioMech ASlead
Study Sites (12)
Cardiovascular Institute of Los Robles Health System
Thousand Oaks, California, 91360, United States
Northwestern University
Evanston, Illinois, 60208, United States
Ascension St. Francis via Christi
Wichita, Kansas, 67226, United States
Mayo Clinic
Rochester, Minnesota, 55902, United States
CentraCare Heart & Vascular Center
Saint Cloud, Minnesota, 56303, United States
NYU Langone
New York, New York, 10016, United States
Atrium Health Sanger Heart and Vascular Institute
Charlotte, North Carolina, 28204, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Ascension St. Thomas West
Nashville, Tennessee, 37205, United States
Baylor Scott & White, The Heart Hospital
Plano, Texas, 75093, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mathew Williams, MD
NYU Langone
- PRINCIPAL INVESTIGATOR
Mayra Guerrero, MD
Mayo Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2021
First Posted
March 29, 2021
Study Start
July 27, 2021
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2031
Last Updated
February 10, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share