At a glance
ClinicalIndex Comparison RecordN/ACompleted· 140 enrolled
Drug / intervention
AVR with AVALUS +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Early and 1-year Hemodynamic Performance and Clinical Outcomes After Aortic Valve Replacement Using Two Pericardial Bioprostheses: A Multicenter Randomized Controlled Trial
In Brief
A clinical study evaluating AVR with AVALUS and AVR with CEPME for Aortic Valve Disease. Completed, enrolled 140 participants across 2 sites.
Detailed 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 Perimount Magna Ease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAortic Valve Disease
CountriesSouth Korea
CollaboratorsSeoul National University Bundang Hospital
Timeline
N/ACompletedFinished
20192020202120222023202420252026
First PostedJan 2019
Enrollment StartJan 2019
Primary CompletionMay 2021
Study CompletionMay 2022
TodayJul 2026
First PostedJan 8, 2019
Enrollment StartJan 23, 2019
Primary CompletionMay 13, 2021
Study CompletionMay 31, 2022
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 7.5 years ago
Interventions
AVR with AVALUSdevice
aortic valve replacement with AVALUS bioprosthesis
AVR with CEPMEdevice
aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis