RECRUITING

EFS of the CardioMech MVRS

Talk to us

Conditions

Mitral Regurgitation

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2021-07-27
Study Completion:2031-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04820764

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Eighteen (18) years of age or greater
  2. * Moderate to severe (≥3+) or severe (≥4+) mitral valve regurgitation (per American Society of Echocardiography (ASE) guidelines) due to mitral valve prolapse or flail
  3. * Intermediate or high surgical risk for mitral valve repair
  1. * History of rheumatic heart disease
  2. * History of prior endocarditis
  3. * History of prior repair or replacement of the mitral valve, or annuloplasty
  4. * Severely calcified mitral leaflet or has evidence of calcification in the grasping area of the leaflets that would prevent leaflet anchor positioning and deployment
  5. * Complex mechanism of MR (leaflet perforation, severe leaflet calcifications, commissural extension, commissural prolapse, multiple flail or prolapsing segments, cleft) present on required imaging

Contacts and Locations

Study Contact

Jennifer Ruether
CONTACT
651-248-4440
jennifer.ruether@cardiomech.com
Rick Nehm
CONTACT
rick.nehm@cardiomech.com

Principal Investigator

Mathew Williams, MD
PRINCIPAL_INVESTIGATOR
NYU Langone
Mayra Guerrero, MD
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: CardioMech AS

  • Mathew Williams, MD, PRINCIPAL_INVESTIGATOR, NYU Langone
  • Mayra Guerrero, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-27
Study Completion Date2031-09

Study Record Updates

Study Start Date2021-07-27
Study Completion Date2031-09

Terms related to this study

Additional Relevant MeSH Terms

  • Mitral Regurgitation