Recruiting

CardioMech MVRSEFS of the CardioMech MVRS

Sponsor:

CardioMech AS

Code:

NCT04820764

Conditions

Mitral Regurgitation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CardioMech MVRS

Study Details

Brief summary:

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

Conditions

Mitral Regurgitation

Study ID

NCT04820764

Start date

Jul 27, 2021

Status verified date

Jan, 2026

Completion date

Sep, 2031

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: CardioMech Mitral Valve Repair System (MVRS)

Interventions

CardioMech MVRS

Primary outcome measure

Freedom from serious adverse events determined to be related to the CardioMech MVRS device or procedure [ Time Frame: 30 days ]
Change in MR grade [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Jennifer Ruether

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

Rick Nehm

rick.nehm@cardiomech.com

Locations

Northwestern University

Recruiting

Evanston, Illinois, United States, 60208

Contacts

Justin Cortez

justin.cortez@nm.org

Principal Investigator:

Charles Davidson, MD

Ascension St. Francis via Christi

Recruiting

Wichita, Kansas, United States, 67226

Contacts

Meredith Thunberg, RN, BSN

Meredith.Thunberg@cckheart.com

Principal Investigator:

Bassem Chehab, MD

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55902

Contacts

Anna Reed

Reed.Anna@mayo.edu

Principal Investigator:

Mayra Guerrero, MD

CentraCare Heart & Vascular Center

Recruiting

Saint Cloud, Minnesota, United States, 56303

Contacts

Jennifer Humbert

HumbertJ@centracare.com

Principal Investigator:

Thom Dahle, MD

NYU Langone

Recruiting

New York, New York, United States, 10016

Contacts

Patricia Kozikowski

Patricia.Kozikowski@nyulangone.org

Principal Investigator:

Mathew Williams, MD

The Christ Hospital

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Jamie Bley

jamie.bley@thechristhospital.com

Principal Investigator:

Santiago Garcia, MD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Shawn McDaniel

MCDANIS4@ccf.org

Principal Investigator:

Samir Kapadia, MD

Ascension St. Thomas West

Recruiting

Nashville, Tennessee, United States, 37205

Contacts

Emily Normandin

emily.normandin@ascension.org

Principal Investigator:

Evelio Rodriguez, MD

Baylor Scott & White, The Heart Hospital

Recruiting

Plano, Texas, United States, 75093

Contacts

Jasmine Kennedy

Jasmine.Kennedy@BSWHealth.org

Principal Investigator:

Robert Smith, MD

Intermountain Medical Center

Recruiting

Murray, Utah, United States, 84107

Contacts

Lexi Maycock

Lexi.Maycock@imail.org

Principal Investigator:

Brian Whisenant, MD

More Information

Sponsor

CardioMech AS

Last update posted

Feb 10, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by CardioMech AS on 2026-02-10.