At a glance
ClinicalIndex Comparison RecordN/ACompleted· 133 enrolled
Drug / intervention
Heart Valve Surgeryprocedure
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.
Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000
In Brief
A clinical study evaluating Heart Valve Surgery for Aortic Valve Disorder and 4 related conditions. Completed, enrolled 133 participants across 2 sites.
Detailed Summary
The purpose of this observational trial is to gather further clinical data to confirm the safety and performance of the Edwards Pericardial Aortic Bioprosthesis, Model 11000 in this trial population.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAortic Valve Disorder, Aortic Valve Insufficiency, Aortic Valve Stenosis, Heart Failure, Coronary Artery Disease
CountriesPoland
Collaborators--
Timeline
N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2011
First PostedJul 2012
Primary CompletionJul 2018
TodayJul 2026
First PostedJul 26, 2012
Enrollment StartJul 1, 2011
Primary CompletionJul 1, 2018
TodayJul 2, 2026
Enrollment to primary: 7 yearsPosted 13.9 years ago
Interventions
Heart Valve Surgeryprocedure
Implant of an aortic valve, Model 11000