WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation
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ClinicalTrials.gov Identifier: NCT00129545 |
Recruitment Status :
Completed
First Posted : August 12, 2005
Results First Posted : May 15, 2015
Last Update Posted : May 15, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Atrial Fibrillation Stroke | Device: WATCHMAN Left Atrial Appendage Closure Technology Drug: Warfarin | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 800 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation (PROTECT AF) |
Study Start Date : | February 2005 |
Actual Primary Completion Date : | August 2013 |
Actual Study Completion Date : | May 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: WATCHMAN
Implant of WATCHMAN Left Atrial Appendage Closure Technology
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Device: WATCHMAN Left Atrial Appendage Closure Technology
Implant of WATCHMAN Left Atrial Appendage Closure Technology
Other Name: WATCHMAN |
Active Comparator: Warfarin control
Subjects are treated with current standard of care Oral Anticoagulation Therapy with Warfarin
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Drug: Warfarin
Subjects receive warfarin
Other Name: Coumadin |
Roll-in
Implant of WATCHMAN Left Atrial Appendage Closure Technology. Up to 3 non-randomized subjects per site, these subjects were not included in the primary analysis.
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Device: WATCHMAN Left Atrial Appendage Closure Technology
Implant of WATCHMAN Left Atrial Appendage Closure Technology
Other Name: WATCHMAN |
- Composite of Stroke, Systemic Embolism and Cardiovascular or Unexplained Death [ Time Frame: 5 years ]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)
- The Occurrence of Life-threatening Events, Including Device Embolization or Serious Bleeding Events [ Time Frame: 5 years ]Serious bleeding events evaluated by the Clinical Events Committee included pericardial effusion requiring drainage, cranial bleeding events due to any source, gastrointestinal bleeds requiring transfusion, and any bleeding related to the device or procedure that necessitates an operation.
- Procedure Success [ Time Frame: Initial implant procedure ]Implant procedure success is defined as the delivery and release of a WATCHMAN Device into the LAA.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient has paroxysmal, persistent or permanent non-valvular atrial fibrillation (AF)
- Eligible for long term warfarin
- CHADS score >= 1 [congestive heart failure (CHF), history of high blood pressure, 75 years of age or older, diabetes, prior stroke or transient ischemic attack (TIA)]
Exclusion Criteria:
- Contraindicated for warfarin
- Contraindicated for aspirin or clopidogrel (Plavix)
- Congestive heart failure (CHF) Class 4
- Implanted mechanical valve
- Atrial septal or Patent Foramen Ovale (PFO) device
- Platelets < 100,000 or hemoglobin < 10
- Left ventricular ejection fraction (LVEF) < 30%

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00129545

Principal Investigator: | David Holmes, MD | Mayo Clinic |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Boston Scientific Corporation |
ClinicalTrials.gov Identifier: | NCT00129545 |
Other Study ID Numbers: |
ST1021 and ST1055 |
First Posted: | August 12, 2005 Key Record Dates |
Results First Posted: | May 15, 2015 |
Last Update Posted: | May 15, 2015 |
Last Verified: | April 2015 |
AF Atrial Fibrillation A Fib Stroke Coumadin Warfarin |
Blood thinning medication transient ischemic attack (TIA) WATCHMAN Left atrial appendage LAA isolation LAA occlusion |
Atrial Fibrillation Cardiovascular Diseases Arrhythmias, Cardiac Heart Diseases |
Pathologic Processes Warfarin Anticoagulants |