At a glance
ClinicalIndex Comparison RecordN/ACompleted· 283 enrolled
Drug / intervention
Implantation of CEP Magna Ease Model 3300TFXdevice
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.
Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis in the Aortic Position, Model 3300TFX
In Brief
A clinical study evaluating Implantation of CEP Magna Ease Model 3300TFX for Coronary Artery Disease and 4 related conditions. Completed, enrolled 283 participants across 13 sites in 6 countries.
Detailed Summary
The purpose of the study is to demonstrate the long term safety and effectiveness of the Carpentier-Edwards PERIMOUNT Magna Ease Valves in patients undergoing aortic valve replacement with or without concomitant procedures requiring cardiopulmonary bypass.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease, Aortic Valve Disorder, Heart Failure, Aortic Valve Stenosis, Aortic Valve Insufficiency
CountriesAustria, Canada, Germany, Spain, United Kingdom, United States
Collaborators--
Timeline
N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2007
First PostedJul 2010
Primary CompletionSep 2018
TodayJul 2026
First PostedJul 28, 2010
Enrollment StartOct 1, 2007
Primary CompletionSep 1, 2018
TodayJul 2, 2026
Enrollment to primary: 10.9 yearsPosted 15.9 years ago
Interventions
Implantation of CEP Magna Ease Model 3300TFXdevice
Heart Valve Surgery