Clinical Trials/NCT04351984

NCT04351984

Completed

Not Applicable

Transcatheter Mitral Valvuloplasty for Severe Mitral Regurgitation Pilot Study

Duk-Woo Park, MD1 site in 1 country5 target enrollmentOctober 20, 2020

ConditionsMitral Valve Insufficiency Mitral Regurgitation Mitral Valve Regurgitation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Mitral Valve Insufficiency
Sponsor: Duk-Woo Park, MD
Enrollment: 5
Locations: 1
Primary Endpoint: Mitral regurgitation
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

October 20, 2020

End Date

December 31, 2021

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Duk-Woo Park, MD

Responsible Party

Sponsor Investigator

Principal Investigator

Duk-Woo Park, MD

Associate Professor, Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine

Asan Medical Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

Mitral regurgitation

Time Frame: 1 month

Secondary Outcomes

Successful valvuloplasty(5 days)
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)

Study Sites (1)

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