EFS of the CardioMech MVRS

Not Applicable

Recruiting

• Conditions: Mitral Regurgitation
• Interventions: Device: CardioMech MVRS

• Registration Number: NCT04820764
• Lead Sponsor: CardioMech AS

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2021-03-25
• Study First Submitted QC: 2021-03-25
• Study First Posted: 2021-03-29
• Study Start: 2021-07-27
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-10
• Primary Completion: 2025-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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, 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CardioMech Mitral Valve Repair System (MVRS)	CardioMech MVRS	-

Primary Outcome Measures

Name	Time	Method
Freedom from serious adverse events determined to be related to the CardioMech MVRS device or procedure	30 days
Change in MR grade	30 days

Trial Locations

Locations (9)

Cardiovascular Institute of Los Robles Health System; 🇺🇸 Thousand Oaks, California, United States

Ascension St. Francis via Christi; 🇺🇸 Wichita, Kansas, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

CentraCare Heart & Vascular Center; 🇺🇸 St. Cloud, Minnesota, United States

NYU Langone; 🇺🇸 New York City, New York, United States

Atrium Health Sanger Heart and Vascular Institute; 🇺🇸 Charlotte, North Carolina, United States

The Christ Hospital; 🇺🇸 Cincinnati, Ohio, United States

Ascension St. Thomas West; 🇺🇸 Nashville, Tennessee, United States

Intermountain Medical Center; 🇺🇸 Murray, Utah, United States