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NCT00129545 · ClinicalTrials.gov registry record · Phase 2
WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation
A Phase 2 study, sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- Phase 2
- Development phase
- 800
- Enrollment target
NCT00129545: Completed Phase 2 study, sponsored by Boston Scientific Corporation.
NCT00129545 is a Phase 2 study that has completed, run by Boston Scientific Corporation. The registered enrollment target is 800 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (502% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00129545, a Phase 2 study, has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 800 participants
- Enrollment target
Study Summary
This is a multi-center, prospective, randomized study, stratified by center, comparing the WATCHMAN device to long term warfarin therapy, demonstrating that the treatment arm is non-inferior to the control arm. This study was amended to allow for a non-randomized arm and increased enrollment.
Primary Outcome
A Bayesian model allowed for sequential evaluation of the primary endpoints, event rates reported per 100 patient-years (calculated as 100\*N events/Total patient-years)
Interventions
- DRUG Warfarin
- DEVICE WATCHMAN Left Atrial Appendage Closure Technology
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 800 participants |
| Start Date | 2005-02 |
| Est. Completion | 2014-05 |
| Phase | Phase 2 |
What the finished NCT00129545 record still lists
NCT00129545 is an interventional study that assigns participants to a tested intervention. The registered 800 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (502% higher).
The record links to 0 conditions, and to 2 interventions - of which Warfarin is the first listed.
NCT00129545 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00129545 about?
NCT00129545 is a clinical study titled "WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation". This is a multi-center, prospective, randomized study, stratified by center, comparing the WATCHMAN device to long term warfarin therapy, demonstrating that the treatment arm is non-inferior to the control arm. This study was amended to allow for a non-randomized arm and increased enrollment.
What is the current status of trial NCT00129545?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 800 participants. The study started on 2005-02. Estimated completion is 2014-05.
What interventions are being tested in trial NCT00129545?
The interventions under investigation include: Warfarin (DRUG), WATCHMAN Left Atrial Appendage Closure Technology (DEVICE).
Who is sponsoring clinical trial NCT00129545?
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 NCT00129545's enrollment target sits among peer trials
800 37th of 2000 higher than 1,961 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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