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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 is a Phase 3 study that has completed, run by Boston Scientific Corporation. The registered enrollment target is 407 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01182441
The ClinicalTrials.gov registry entry for NCT01182441 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 407 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Scientific Corporation, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Warfarin is the first listed.
NCT01182441 reports 0 study locations.
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.
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