Transcatheter Mitral Valvuloplasty Pilot Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-20

Study Completion Date

2021-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Mitral Valve Insufficiency Mitral Regurgitation Mitral Valve Regurgitation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Severe Mitral Regurgitation

MitraClip

Intervention Type DEVICE

Transcatheter Mitral Valvuloplasty with MitraClip

Interventions

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MitraClip

Transcatheter Mitral Valvuloplasty with MitraClip

Intervention Type DEVICE

Other Intervention Names

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Transcatheter Mitral Valvuloplasty

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No