CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 329 enrolled
Drug / intervention
CEP MAGNA MITRAL PERICARDIAL BIOPROSTHESESdevice
Likely dose
Carpentier-Edwards Perimount Magna mitral bioprostheses (models 7000, 7000 TFX, 7200TFX, 7300, 7300TFX)AI-extracted
Key inclusion· 5
  • ✓Patient requires mitral valve replacement as indicated by preoperative evaluation
  • ✓Age ≥18 years
  • ✓Expected to survive surgery and be discharged
  • ✓Geographically stable and willing to attend follow-up assessments
Key exclusion· 8
  • ✕Any known non-cardiac life-threatening disease limiting life expectancy to <1 year
  • ✕Active endocarditis within the last 3 months
  • ✕Pregnant or lactating
  • ✕Intravenous drug abuser

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00853632
NCT00853632N/ACompleted
CompareCT.gov

Carpentier-Edwards® Perimount Magna® Mitral Pericardial Bioprostheses Models 7000/7000 TFX and Carpentier-Edwards® Perimount Magna® Mitral Ease™ Pericardial Bioprostheses Models 7200TFX and 7300/7300TFX

Edwards Lifesciences·interventional·Posted Mar 2, 2009·Updated May 14, 2025

In Brief

A clinical study evaluating CEP MAGNA MITRAL PERICARDIAL BIOPROSTHESES for Coronary Artery Disease and 3 related conditions. Completed, enrolled 329 participants across 15 sites in 4 countries.

Detailed Summary

The purpose of the study is to demonstrate the long term safety and effectiveness of the Carpentier-Edwards® PERIMOUNT Magna Mitral Valves in patients undergoing mitral valve replacement with or without concomitant procedures requiring cardiopulmonary bypass.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease, Mitral Valve Regurgitation, Mitral Valve Incompetence, Heart Failure
CountriesAustria, Canada, Germany, United States
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 2, 2009
Enrollment StartAug 1, 2007
Primary CompletionMar 6, 2024
TodayJul 2, 2026
Enrollment to primary: 16.6 yearsPosted 17.3 years ago

Interventions

CEP MAGNA MITRAL PERICARDIAL BIOPROSTHESESdevice

Mitral valve replacement