Transcatheter Mitral Valvuloplasty Pilot Study

Mitral Regurgitation Clinical Trial

— MitraClip  

Official title:

Transcatheter Mitral Valvuloplasty for Severe Mitral Regurgitation Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04351984
• Other study ID #: AMCCV2020-04
• Status: Completed
• Start date: October 20, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2022
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 31, 2021
• Est. primary completion date: December 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency
• Mitral Valve Regurgitation

Intervention

Device:
• MitraClip
Transcatheter Mitral Valvuloplasty with MitraClip

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Duk-Woo Park, MD	CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mitral regurgitation		1 month
Secondary	All cause death		1 year
Secondary	Stroke		1 year
Secondary	Myocardial infarction		1 year
Secondary	Re-hospitalization		1 year
Secondary	Acute kidney dysfunction		5 days
Secondary	Vascular complication		5 days
Secondary	Bleeding		5 days
Secondary	Successful valvuloplasty	No significant complication	5 days