Transcatheter Mitral Valvuloplasty Pilot Study
Completed
- Conditions
- Mitral Valve InsufficiencyMitral RegurgitationMitral Valve Regurgitation
- Registration Number
- NCT04351984
- Lead Sponsor
- Duk-Woo Park, MD
- Brief Summary
This study is to evaluate the efficacy and safety of Transcatheter Mitral Valvuloplasty for Severe Mitral Regurgitation
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mitral regurgitation 1 month
- Secondary Outcome Measures
Name Time Method Successful valvuloplasty 5 days No significant complication
All cause death 1 year Re-hospitalization 1 year Acute kidney dysfunction 5 days Vascular complication 5 days Bleeding 5 days Stroke 1 year Myocardial infarction 1 year
Trial Locations
- Locations (1)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Asan Medical Center🇰🇷Seoul, Korea, Republic of