EFS of the CardioMech MVRS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-27

Study Completion Date

2031-09-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Mitral Regurgitation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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CardioMech Mitral Valve Repair System (MVRS)

Group Type EXPERIMENTAL

CardioMech MVRS

Intervention Type DEVICE

CardioMech MVRS

Interventions

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CardioMech MVRS

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No