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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 is a Phase 2 study that has completed, run by Boston Scientific Corporation. The registered enrollment target is 800 participants.

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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.

Interventions

  • DRUG Warfarin
  • DEVICE WATCHMAN Left Atrial Appendage Closure Technology

Trial Details

FieldValue
Enrollment Target 800 participants
Start Date 2005-02
Est. Completion 2014-05
Phase Phase 2

Sponsor

Boston Scientific Corporation

280 total trials

What the Registry Record Tells You About NCT00129545

The ClinicalTrials.gov registry entry for NCT00129545 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 800 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.

NCT00129545 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.