At a glance
ClinicalIndex Comparison RecordN/ACompleted· 777 enrolled
Drug / intervention
Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000Mdevice
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.
ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Aortic and Mitral Bioprostheses (Models 11000A and 11000M) With a New Tissue Treatment Platform (COMMENCE)
In Brief
A clinical study evaluating Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M for Aortic Stenosis and 4 related conditions. Completed, enrolled 777 participants across 32 sites in 3 countries.
Detailed Summary
The objective of this trial is to confirm that the modifications to tissue processing, valve sterilization and packaging do not raise any new questions of safety and effectiveness in subjects who require replacement of their native or prosthetic aortic or mitral valve.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAortic Stenosis, Mitral Stenosis, Aortic Valve Insufficiency, Mitral Valve Insufficiency, Heart Failure
CountriesCanada, Poland, United States
Collaborators--
Timeline
N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2012
First PostedDec 2012
Primary CompletionAug 2017
Study CompletionMar 2026
TodayJul 2026
First PostedDec 31, 2012
Enrollment StartDec 11, 2012
Primary CompletionAug 1, 2017
Study CompletionMar 23, 2026
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 13.5 years ago
Interventions
Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000Mdevice
Implant of an aortic valve, Model 11000A or mitral valve, Model 11000M