EFS of the CardioMech MVRS

Recruiting now · Not applicable

Conditions studied: Mitral Regurgitation

In brief

Safety and performance evaluation of the CardioMech Mitral Valve Repair System (MVRS) in patients with degenerative mitral valve regurgitation.

Key facts

Study ID

NCT04820764

Run by

CardioMech AS

People needed

25

Starts

2021-07-27

Expected to finish

2031-09-01

Last updated by the study team

2026-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Baylor Scott & White, The Heart Hospital — Plano, Texas, United States (enrolling)
• Intermountain Medical Center — Murray, Utah, United States (enrolling)
• Ascension St. Francis via Christi — Wichita, Kansas, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• CentraCare Heart & Vascular Center — Saint Cloud, Minnesota, United States (enrolling)
• NYU Langone — New York, New York, United States (enrolling)
• Northwestern University — Evanston, Illinois, United States (enrolling)
• The Christ Hospital — Cincinnati, Ohio, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• Ascension St. Thomas West — Nashville, Tennessee, United States (enrolling)
• Atrium Health Sanger Heart and Vascular Institute — Charlotte, North Carolina, United States
• Cardiovascular Institute of Los Robles Health System — Thousand Oaks, California, United States

Full record on ClinicalTrials.gov

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