Status:
WITHDRAWN
Percutaneous Device Closure for Significant Paravalvular Leakage After Transcatheter or Surgical Valve Replacement
Lead Sponsor:
Seung-Jung Park
Collaborating Sponsors:
CardioVascular Research Foundation, Korea
Conditions:
Cardiac Valves
Heart Valve Diseases
Eligibility:
All Genders
20+ years
Phase:
NA
Brief Summary
This study evaluates the effectiveness and safety of Percutaneous Device Closure for Significant Paravalvular Leakage after transcatheter or surgical valve replacement.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03793296
Start Date
January 31 2019
End Date
December 31 2026
Last Update
February 1 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Asan Medical Center
Seoul, South Korea