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CardioMech MVRS for Mitral Regurgitation

This study is evaluating the safety and performance of a device called the CardioMech Mitral Valve Repair System (MVRS). This device is for people with moderate to severe or severe mitral regurgitation (a condition where the heart's mitral valve doesn't close properly, causing blood to leak backward). You might be able to join if you are 18 or older, have this type of mitral regurgitation due to a prolapsed or flail mitral valve, and are considered to be at intermediate or high risk for surgery. The study will look at how well the device prevents serious problems and how much it improves your mitral regurgitation within 30 days. The study plans to enroll 25 participants, but its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive the CardioMech MVRS device. It plans to enroll 25 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 30 days to assess for serious adverse events and changes in mitral regurgitation grade.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04820764

EFS of the CardioMech MVRS

Recruiting
NAAges 18+InterventionalDevice feasibility
CardioMech AS
~25 participants
Updated 2026-02-10 on ClinicalTrials.gov
What's tested:CardioMech MVRS

At a glance

Recruiting sites
10 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Freedom from serious adverse events determined to be related to the CardioMech MVRS device or procedure
Measured over 30 days
+1 more outcome measured

Conditions

Mitral Regurgitation

Explore related trials

Mitral Valve Insufficiency

Where it's being run

12 sites across 10 states
Minnesota2
Ohio2
California1
Illinois1
Kansas1
New York1
North Carolina1
Tennessee1

Study leadership

  • Mathew Williams, MD · PRINCIPAL_INVESTIGATOR · NYU Langone
  • Mayra Guerrero, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Jennifer Ruether
[email protected]
651-248-4440
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Freedom from serious adverse events determined to be related to the CardioMech MVRS device or procedure30 days
  • Change in MR grade30 days