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Completed

NCT Number: NCT04351984

Transcatheter Mitral Valvuloplasty Pilot Study

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

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Asan Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mitraclip

Device

Transcatheter Mitral Valvuloplasty with MitraClip

Other names: Transcatheter Mitral Valvuloplasty

Primary outcomes

  1. Mitral regurgitation

    Time frame: 1 month

Secondary outcomes

  1. All cause death

    Time frame: 1 year

  2. Stroke

    Time frame: 1 year

  3. Myocardial infarction

    Time frame: 1 year

  4. Re-hospitalization

    Time frame: 1 year

  5. Acute kidney dysfunction

    Time frame: 5 days

  6. Vascular complication

    Time frame: 5 days

  7. Bleeding

    Time frame: 5 days

  8. Successful valvuloplasty

    Time frame: 5 days

    No significant complication

Sponsors and collaborators

Lead sponsor

Duk-Woo Park, MD

Other

Collaborators

  • CardioVascular Research Foundation, Korea

Registry information

Official study title

Transcatheter Mitral Valvuloplasty for Severe Mitral Regurgitation Pilot Study

Acronym: MitraClip

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 17, 2020
Registry last updated
Feb 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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