Transcatheter Mitral Valvuloplasty Pilot Study (MitraClip)

Duk-Woo Park, MD

Status: Completed

Conditions: Mitral Valve Regurgitation; Mitral Valve Insufficiency; Mitral Regurgitation

Treatments: Device: MitraClip

Study type: Observational

Funder types: Other

Identifiers

NCT04351984

AMCCV2020-04

Details and patient eligibility

About

This study is to evaluate the efficacy and safety of Transcatheter Mitral Valvuloplasty for Severe Mitral Regurgitation

Enrollment: 5 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Significant symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.
• Age 19 and more
• Written informed consent

Exclusion criteria

• Patients who cannot tolerate procedural anticoagulation or post-procedural antiplatelet regimen
• Active endocarditis of the mitral valve
• Rheumatic mitral valve disease
• Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus

Trial design

5 participants in 1 patient group

Severe Mitral Regurgitation

Treatment:

Device: MitraClip