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NCT01182441 · ClinicalTrials.gov registry record · Phase 3
Evaluation of the WATCHMAN Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy
A Phase 3 study, sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 407
- Enrollment target
NCT01182441: Completed Phase 3 study, sponsored by Boston Scientific Corporation.
NCT01182441 is a Phase 3 study that has completed, run by Boston Scientific Corporation. The registered enrollment target is 407 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01182441, a Phase 3 study, has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 407 participants
- Enrollment target
Study Summary
This was a prospective, randomized, multicenter study to provide additional information on the safety and efficacy of the WATCHMAN LAA Closure Technology. The purpose of the PREVAIL study was to confirm the efficacy endpoint as demonstrated in the PROTECT AF pivotal study and to further demonstrate that the WATCHMAN LAA Closure Technology is safe and effective in subjects with non-valvular atrial fibrillation who require anticoagulation therapy for potential thrombus formation.
Primary Outcome
7-Day procedure rate of death, ischemic stroke, systemic embolism and complications requiring major cardiovascular or endovascular intervention.
Interventions
- DRUG Warfarin
- DEVICE WATCHMAN Device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 407 participants |
| Start Date | 2010-11 |
| Est. Completion | 2017-11 |
| Phase | Phase 3 |
What the finished NCT01182441 record still lists
NCT01182441 is an interventional study that assigns participants to a tested intervention. The registered 407 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 2 interventions - of which Warfarin is the first listed.
NCT01182441 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01182441 about?
NCT01182441 is a clinical study titled "Evaluation of the WATCHMAN Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy". This was a prospective, randomized, multicenter study to provide additional information on the safety and efficacy of the WATCHMAN LAA Closure Technology. The purpose of the PREVAIL study was to confirm the efficacy endpoint as demonstrated in the PROTECT AF pivotal study and to further demonstrate ...
What is the current status of trial NCT01182441?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 407 participants. The study started on 2010-11. Estimated completion is 2017-11.
What interventions are being tested in trial NCT01182441?
The interventions under investigation include: Warfarin (DRUG), WATCHMAN Device (DEVICE).
Who is sponsoring clinical trial NCT01182441?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01182441's enrollment target sits among peer trials
407 913th of 2000 higher than 1,088 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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