Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04820764

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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