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NCT04820764 Clinical Trial

EFS of the CardioMech MVRS

Mitral Regurgitation Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04820764
Other study ID # 10228
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 27, 2021
Est. completion date June 2029

Study information
Verified date May 2024
Source CardioMech AS
Contact Danielle Dusenberry
Phone 631-365-9399
Email Danielle.Dusenberry@cardiomech.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

The purpose of the clinical study is to obtain clinical data on the CardioMech Mitral Valve Repair System (MVRS) in patients diagnosed with moderate to severe (≥3+) or severe (≥4+), symptomatic, degenerative mitral regurgitation and who are determined to be at intermediate or high surgical risk for mitral valve repair, as assessed by the site's multidisciplinary heart team.

Recruitment information / eligibility
Status Recruiting
Enrollment 10
Est. completion date June 2029
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion 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 Exclusion Criteria: - History of rheumatic heart disease - History of prior endocarditis - History of prior repair or replacement of the mitral valve, annuloplasty or valvuloplasty or has a left atrial appendage closure device - 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• CardioMech MVRS
CardioMech MVRS

Locations
Country Name City State
United States Atrium Health Sanger Heart and Vascular Institute Charlotte North Carolina
United States Intermountain Medical Center Murray Utah
United States Ascension St. Thomas West Nashville Tennessee
United States NYU Langone New York New York
United States Mayo Clinic Rochester Minnesota
United States CentraCare Heart & Vascular Center Saint Cloud Minnesota
United States Cardiovascular Institute of Los Robles Health System Thousand Oaks California
United States Ascension St. Francis via Christi Wichita Kansas

Sponsors (1)
Lead Sponsor Collaborator
CardioMech AS

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Freedom from serious adverse events determined to be related to the CardioMech MVRS device or procedure 30 days
Primary Change in MR grade 30 days
See also
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Suspended NCT00787293 - Study of Safety and Efficacy of the Percutaneous Reduction of Mitral Valve Regurgitation in Heart Failure Patients Phase 2