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Magna® Mitral Pericardial Bioprostheses Post-Approval Study Protocol

NCT00853632 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 329

Last updated 2025-05-14

Study results available
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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.

Conditions

Interventions

DEVICE

CEP MAGNA MITRAL PERICARDIAL BIOPROSTHESES

Mitral valve replacement

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2024-03-06
Completion
2024-03-06
FDA Device
Yes

Countries

  • United States
  • Austria
  • Canada
  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00853632 on ClinicalTrials.gov