At a glance
ClinicalIndex Comparison RecordN/ACompleted· 39 enrolled
Drug / intervention
Implantation of CEP Magna Mitral Model 7000TFXdevice
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 Evaluation of the Size 23mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
In Brief
A clinical study evaluating Implantation of CEP Magna Mitral Model 7000TFX for Mitral Heart Valve Disease. Completed, enrolled 39 participants across 6 sites in 2 countries.
Detailed Summary
The purpose of this clinical study is to obtain human clinical data that demonstrates that the size 23mm Carpentier-Edwards PERIMOUNT Magna mitral pericardial valve, model 7000TFX, is a safe and effective replacement heart valve.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMitral Heart Valve Disease
CountriesPoland, United States
Collaborators--
Timeline
N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2011
First PostedMar 2011
Primary CompletionNov 2018
TodayJul 2026
First PostedMar 11, 2011
Enrollment StartMar 1, 2011
Primary CompletionNov 1, 2018
TodayJul 2, 2026
Enrollment to primary: 7.7 yearsPosted 15.3 years ago
Interventions
Implantation of CEP Magna Mitral Model 7000TFXdevice
Heart valve surgery: CEP Magna Mitral Model 7000 TFX