Evaluation of the CardioMech Mitral Valve Repair System

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

This study is testing a new device to see if it can safely help people with serious mitral valve problems who are at risk for surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: CardioMech AS (industry)
• Locations: 12 sites (Thousand Oaks, California and 11 other locations)
• Trial ID: NCT04820764 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the safety and performance of the CardioMech Mitral Valve Repair System (MVRS) in patients suffering from moderate to severe degenerative mitral regurgitation. It focuses on individuals who are at intermediate or high surgical risk for mitral valve repair, as determined by a multidisciplinary heart team. Participants will receive the CardioMech MVRS, and clinical data will be collected to assess its effectiveness in treating their condition.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with moderate to severe symptomatic degenerative mitral regurgitation.

Not a fit: Patients with a history of rheumatic heart disease, prior endocarditis, or complex mitral regurgitation mechanisms may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less invasive treatment option for patients with significant mitral regurgitation who are at high surgical risk.

How similar studies have performed: Other studies have shown promise in similar approaches to mitral valve repair, indicating potential for success with this novel device.

Eligibility criteria

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

Where this trial is running

Thousand Oaks, California and 11 other locations

• Cardiovascular Institute of Los Robles Health System — Thousand Oaks, California, United States (ACTIVE_NOT_RECRUITING)
• Northwestern University — Evanston, Illinois, United States (RECRUITING)
• Ascension St. Francis via Christi — Wichita, Kansas, United States (RECRUITING)
• Mayo Clinic — Rochester, Minnesota, United States (RECRUITING)
• CentraCare Heart & Vascular Center — Saint Cloud, Minnesota, United States (RECRUITING)
• NYU Langone — New York, New York, United States (RECRUITING)
• Atrium Health Sanger Heart and Vascular Institute — Charlotte, North Carolina, United States (ACTIVE_NOT_RECRUITING)
• The Christ Hospital — Cincinnati, Ohio, United States (RECRUITING)
• Cleveland Clinic — Cleveland, Ohio, United States (RECRUITING)
• Ascension St. Thomas West — Nashville, Tennessee, United States (RECRUITING)
• Baylor Scott & White, The Heart Hospital — Plano, Texas, United States (RECRUITING)
• Intermountain Medical Center — Murray, Utah, United States (RECRUITING)

Study contacts

• Principal investigator: Mathew Williams, MD — NYU Langone
• Study coordinator: Jennifer Ruether

Conditions: Mitral Regurgitation