EFS of the CardioMech MVRS

Description

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

Conditions

Mitral Regurgitation

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Study Overview

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Study Details

Study overview

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

Early Feasibility Study of the CardioMech Mitral Valve Repair System (MVRS)

EFS of the CardioMech MVRS

Condition
Mitral Regurgitation
Intervention / Treatment

-

Contacts and Locations

Thousand Oaks

Cardiovascular Institute of Los Robles Health System, Thousand Oaks, California, United States, 91360

Wichita

Ascension St. Francis via Christi, Wichita, Kansas, United States, 67226

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55902

St. Cloud

CentraCare Heart & Vascular Center, St. Cloud, Minnesota, United States, 56303

New York City

NYU Langone, New York City, New York, United States, 10016

Charlotte

Atrium Health Sanger Heart and Vascular Institute, Charlotte, North Carolina, United States, 28204

Nashville

Ascension St. Thomas West, Nashville, Tennessee, United States, 37205

Murray

Intermountain Medical Center, Murray, Utah, United States, 84107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

CardioMech AS,

Mathew Williams, MD, PRINCIPAL_INVESTIGATOR, NYU Langone

Mayra Guerrero, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

2030-12