Percutaneous Device Closure for Significant Paravalvular Leakage After Transcatheter or Surgical Valve Replacement
NCT ID: NCT03793296
Last Updated: 2019-02-01
Study Results
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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WITHDRAWN
NA
INTERVENTIONAL
2019-01-31
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Paravalvular leak
After transcatheter- or surgical valve replacement
Percutaneous Device Closure: Vascular plug
percutaneous transcatheter approach into cardiac valve
Interventions
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Percutaneous Device Closure: Vascular plug
percutaneous transcatheter approach into cardiac valve
Eligibility Criteria
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Inclusion Criteria
* Required treatment of paravalvular leakage due to heart failure or hemolysis
* There is a formal agreement of heart team as following
* predicted high-risk (STS score ≥8 OR Logistic EuroSCORE ≥20% OR operative mortality is ≥15%)
* Inoperable status due to old age or frailty
* Written consent
Exclusion Criteria
* Acute myocardial ischemia (enzyme elevation, ST elevation on EKG(electrocardiogram), or chest pain/discomfort)
* Evidence of intracardiac mass, thrombus or vegetation on Transthoracic/Transesophageal echocardiographic study
* Life expectancy less than 6 months due to non-cardiac disease
* Pregnant or breastfeeding
20 Years
ALL
No
Sponsors
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CardioVascular Research Foundation, Korea
OTHER
Seung-Jung Park
OTHER
Responsible Party
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Seung-Jung Park
Professor, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
Locations
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Asan Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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AMCCV2018-11
Identifier Type: -
Identifier Source: org_study_id
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