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EFS of the CardioMech MVRS | Clinical Trials | Clareo Health

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RECRUITINGNANCT04820764

EFS of the CardioMech MVRS

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

Lead sponsor: CardioMech AS•12 U.S. locations•View source on ClinicalTrials.gov

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Contacts

Jennifer Ruether

CONTACT

651-248-4440 jennifer.ruether@cardiomech.com

Rick Nehm

CONTACT

rick.nehm@cardiomech.com

Sponsors

Lead Sponsor

CardioMech AS

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.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: February 10, 2026Terms

Trial snapshot

StatusRECRUITING

PhaseNA

Enrollment25

Start dateJul 2021

Last updatedFeb 10, 2026

Condition

Mitral Regurgitation

Locations shown

Cardiovascular Institute of Los Robles Health System

Thousand Oaks, California

Northwestern University

Evanston, Illinois

Ascension St. Francis via Christi

Wichita, Kansas

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 10, 2026Data synced to Clareo: May 17, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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