EFS of the CardioMech MVRS

February 9, 2024 updated by: CardioMech AS

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Thousand Oaks, California, United States, 91360
        • Recruiting
        • Cardiovascular Institute of Los Robles Health System
        • Contact:
        • Principal Investigator:
          • Saibal Kar, MD
    • Kansas
      • Wichita, Kansas, United States, 67226
        • Recruiting
        • Ascension St. Francis via Christi
        • Principal Investigator:
          • Bassem Chehab, MD
        • Contact:
        • Principal Investigator:
          • Brett Grizzell, MD
    • Minnesota
      • Rochester, Minnesota, United States, 55902
        • Active, not recruiting
        • Mayo Clinic
      • Saint Cloud, Minnesota, United States, 56303
        • Recruiting
        • CentraCare Heart & Vascular Center
        • Principal Investigator:
          • Thom Dahle, MD
        • Contact:
    • New York
      • New York, New York, United States, 10016
        • Active, not recruiting
        • NYU Langone
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Atrium Health Sanger Heart and Vascular Institute
        • Principal Investigator:
          • Michael Rinaldi, MD
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37205
        • Recruiting
        • Ascension St. Thomas West
        • Principal Investigator:
          • Evelio Rodriguez, MD
        • Contact:
        • Principal Investigator:
          • Andrew Morse, MD
    • Utah
      • Murray, Utah, United States, 84107
        • Active, not recruiting
        • Intermountain Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CardioMech Mitral Valve Repair System (MVRS)
Device: CardioMech MVRS
CardioMech MVRS

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CardioMech AS

Investigators

  • Principal Investigator: Mathew Williams, MD, NYU Langone
  • Principal Investigator: Mayra Guerrero, MD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2021

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

March 25, 2021

First Submitted That Met QC Criteria

March 25, 2021

First Posted (Actual)

March 29, 2021

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 9, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10228

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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