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NCT01171625 · ClinicalTrials.gov registry record · NA
Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis, Model 3300TFX
A NA study, sponsored by Edwards Lifesciences.
- Completed
- Registry status
- NA
- Development phase
- 283
- Enrollment target
NCT01171625: Completed NA study, sponsored by Edwards Lifesciences.
NCT01171625 is a NA study that has completed, run by Edwards Lifesciences. The registered enrollment target is 283 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01171625, a NA study, has completed, sponsored by Edwards Lifesciences.
- COMPLETED
- Registry status
- NA
- Development phase
- 283 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 Ease Valves in patients undergoing aortic valve replacement with or without concomitant procedures requiring cardiopulmonary bypass.
Primary Outcome
Long term safety performance will be evaluated by comparing the linearized yearly rates to the objective performance criteria (OPC) referenced in the Food and Drug Administration (FDA) 1994 Draft Heart Valve Guidance. Expressed as the Number of late events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).
Interventions
- DEVICE Implantation of CEP Magna Ease Model 3300TFX
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 283 participants |
| Start Date | 2007-10 |
| Est. Completion | 2018-09 |
| Phase | NA |
What the finished NCT01171625 record still lists
NCT01171625 is an interventional study that assigns participants to a tested intervention. The registered 283 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 (80% lower).
The record links to 0 conditions, and to 1 intervention - of which Implantation of CEP Magna Ease Model 3300TFX is the first listed.
NCT01171625 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01171625 about?
NCT01171625 is a clinical study titled "Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis, Model 3300TFX". 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.
What is the current status of trial NCT01171625?
This trial is currently completed. It is a NA study. The enrollment target is 283 participants. The study started on 2007-10. Estimated completion is 2018-09.
What interventions are being tested in trial NCT01171625?
The interventions under investigation include: Implantation of CEP Magna Ease Model 3300TFX (DEVICE).
Who is sponsoring clinical trial NCT01171625?
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 NCT01171625's enrollment target sits among peer trials
283 378th of 2000 higher than 1,622 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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