EFS of the CardioMech MVRS

CardioMech

Status: Enrolling

Conditions: Mitral Regurgitation

Treatments: Device: CardioMech MVRS

Study type: Interventional

Funder types: Industry

Identifiers

NCT04820764

10228

Details and patient eligibility

About

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

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

CardioMech Mitral Valve Repair System (MVRS)

Experimental group

Treatment:

Device: CardioMech MVRS