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NCT02656290 · ClinicalTrials.gov registry record · NA
COMMENCE Pulmonary: Clinical Evaluation of Edwards Pericardial Aortic Bioprosthesis (Model 11000A) for Pulmonary Valve Replacement
A NA study, sponsored by Edwards Lifesciences.
- Completed
- Registry status
- NA
- Development phase
- 26
- Enrollment target
NCT02656290: Completed NA study, sponsored by Edwards Lifesciences.
NCT02656290 is a NA study that has completed, run by Edwards Lifesciences. The registered enrollment target is 26 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02656290, a NA study, has completed, sponsored by Edwards Lifesciences.
- COMPLETED
- Registry status
- NA
- Development phase
- 26 participants
- Enrollment target
Study Summary
The objective of this trial is to assess the safety and effectiveness of the Edwards Pericardial Aortic Bioprosthesis Model 11000A, in the pulmonary position in pediatric and adult subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.
Primary Outcome
Subject's freedom from device or procedure related death and/or reoperation at 1-year post-implant. Time to events were estimated by Kaplan-Meier method. A higher number means a better outcome.
Interventions
- DEVICE Edwards Pericardial Aortic Bioprosthesis Model 11000A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2015-12 |
| Est. Completion | 2022-11-28 |
| Phase | NA |
What the finished NCT02656290 record still lists
NCT02656290 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Edwards Pericardial Aortic Bioprosthesis Model 11000A is the first listed.
NCT02656290 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02656290 about?
NCT02656290 is a clinical study titled "COMMENCE Pulmonary: Clinical Evaluation of Edwards Pericardial Aortic Bioprosthesis (Model 11000A) for Pulmonary Valve Replacement". The objective of this trial is to assess the safety and effectiveness of the Edwards Pericardial Aortic Bioprosthesis Model 11000A, in the pulmonary position in pediatric and adult subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.
What is the current status of trial NCT02656290?
This trial is currently completed. It is a NA study. The enrollment target is 26 participants. The study started on 2015-12. Estimated completion is 2022-11-28.
What interventions are being tested in trial NCT02656290?
The interventions under investigation include: Edwards Pericardial Aortic Bioprosthesis Model 11000A (DEVICE).
Who is sponsoring clinical trial NCT02656290?
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 NCT02656290's enrollment target sits among peer trials
26 1710th of 2000 higher than 289 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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