Percutaneous Device Closure for Significant Paravalvular Leakage After Transcatheter or Surgical … (NCT03793296) | Clinical Trial Compass
WithdrawnNot Applicable
Percutaneous Device Closure for Significant Paravalvular Leakage After Transcatheter or Surgical Valve Replacement
Stopped: At sponsor's discretion
South Korea0Started 2019-01-31
Plain-language summary
This study evaluates the effectiveness and safety of Percutaneous Device Closure for Significant Paravalvular Leakage after transcatheter or surgical valve replacement.
Who can participate
Age range20 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Significant Paravalvular Leakage After Transcatheter or Surgical Valve Replacement
* 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:
* Risk of valve embolization because of valve dehiscence or instability
* 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