Status:
COMPLETED
Transcatheter Mitral Valvuloplasty Pilot Study
Lead Sponsor:
Duk-Woo Park, MD
Collaborating Sponsors:
CardioVascular Research Foundation, Korea
Conditions:
Mitral Valve Insufficiency
Mitral Regurgitation
Eligibility:
All Genders
19+ years
Brief Summary
This study is to evaluate the efficacy and safety of Transcatheter Mitral Valvuloplasty for Severe Mitral Regurgitation
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 20 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04351984
Start Date
October 20 2020
End Date
December 31 2021
Last Update
February 24 2022
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea