WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation

Study Overview
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Brief Summary
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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.

Detailed Description
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The WATCHMAN device is designed to be permanently implanted distal to the ostium of the left atrial appendage (LAA) to trap potential emboli before they exit the LAA.

Official Title
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WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation (PROTECT AF)

Conditions
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Atrial Fibrillation, Stroke

Intervention / Treatment
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* Device: WATCHMAN Left Atrial Appendage Closure Technology
* Drug: Warfarin


Participation Criteria
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Eligibility Criteria
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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%

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WATCHMAN<br>Implant of WATCHMAN Left Atrial Appendage Closure Technology | Device: WATCHMAN Left Atrial Appendage Closure Technology<br>* Implant of WATCHMAN Left Atrial Appendage Closure Technology<br>* Other names: WATCHMAN;|
| Active Comparator: Warfarin control<br>Subjects are treated with current standard of care Oral Anticoagulation Therapy with Warfarin | Drug: Warfarin<br>* Subjects receive warfarin<br>* Other names: Coumadin;|
| Other: Roll-in<br>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. | Device: WATCHMAN Left Atrial Appendage Closure Technology<br>* Implant of WATCHMAN Left Atrial Appendage Closure Technology<br>* Other names: WATCHMAN;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of Stroke, Systemic Embolism and Cardiovascular or Unexplained Death | 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) | 5 years | 
| The Occurrence of Life-threatening Events, Including Device Embolization or Serious Bleeding Events | 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. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure Success | Implant procedure success is defined as the delivery and release of a WATCHMAN Device into the LAA. | Initial implant procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, AF, A Fib, Stroke, Coumadin, Warfarin, Blood thinning medication, transient ischemic attack (TIA), WATCHMAN, Left atrial appendage, LAA isolation, LAA occlusion