Status:
COMPLETED
Comparison of Two Pericardial Bioprostheses in AVR
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Seoul National University Bundang Hospital
Conditions:
Aortic Valve Disease
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
The purpose of the study is to compare early and 1-year hemodynamic performance and clinical outcomes after aortic valve replacement using two pericardial bioprosthesis, Avalus and Carpentier Edwards ...
Detailed Description
This trial was designed as a multicenter randomized, controlled trial to recruit 386 patients who undergo aortic valve replacement with pericardial bioprosthesis. Patients were randomized by use of a ...
Eligibility Criteria
Inclusion
- patients who are going to undergo aortic valve replacement with bioprosthesis
Exclusion
- heart failure with severe LV dysfunction (LV EF \<30%)
- active infective endocarditis
- with other critical cardiovascular disease (e.g. acute aortic dissection)
- with other critical comorbities by which the expected life span is less than 1 year
- inadequate participant by the researcher's discretion
Key Trial Info
Start Date :
January 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2022
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT03796442
Start Date
January 23 2019
End Date
May 31 2022
Last Update
February 8 2023
Active Locations (2)
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1
Seoul National University Bundang Hospital
Seongnam, South Korea
2
Seoul National University Hospital
Seoul, South Korea