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NCT00853632 · ClinicalTrials.gov registry record · NA
Magna® Mitral Pericardial Bioprostheses Post-Approval Study Protocol
A NA study, sponsored by Edwards Lifesciences.
- Completed
- Registry status
- NA
- Development phase
- 329
- Enrollment target
NCT00853632: Completed NA study, sponsored by Edwards Lifesciences.
NCT00853632 is a NA study that has completed, run by Edwards Lifesciences. The registered enrollment target is 329 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00853632, a NA study, has completed, sponsored by Edwards Lifesciences.
- COMPLETED
- Registry status
- NA
- Development phase
- 329 participants
- Enrollment target
Study 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.
Primary Outcome
A linearized rate percentage is calculated by the following equation: \[(Total number of late adverse events in each category/total number of late patient years) x 100\]. Late adverse events are events that occur ≥ 31 days post-implant through each subject's last follow-up visit or contact. Late patient years are calculated by totaling the amount of time the valve is implanted in the patient while participating in the trial and the count begins at ≥ 31 days post-implant through all subject's las
Interventions
- DEVICE CEP MAGNA MITRAL PERICARDIAL BIOPROSTHESES
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 329 participants |
| Start Date | 2007-08 |
| Est. Completion | 2024-03-06 |
| Phase | NA |
What the finished NCT00853632 record still lists
NCT00853632 is an interventional study that assigns participants to a tested intervention. The registered 329 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which CEP MAGNA MITRAL PERICARDIAL BIOPROSTHESES is the first listed.
NCT00853632 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00853632 about?
NCT00853632 is a clinical study titled "Magna® Mitral Pericardial Bioprostheses Post-Approval Study Protocol". 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.
What is the current status of trial NCT00853632?
This trial is currently completed. It is a NA study. The enrollment target is 329 participants. The study started on 2007-08. Estimated completion is 2024-03-06.
What interventions are being tested in trial NCT00853632?
The interventions under investigation include: CEP MAGNA MITRAL PERICARDIAL BIOPROSTHESES (DEVICE).
Who is sponsoring clinical trial NCT00853632?
This trial is sponsored by Edwards Lifesciences, which has 57 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00853632's enrollment target sits among peer trials
329 308th of 2000 higher than 1,693 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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