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

Coronary Artery Disease - PROTECT AF

Trial Sponsor
Aritech

Principal Investigator
Gregory J. Mishkel, MD

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

Purpose
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.

Details
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.

Phase
Atrial Fibrillation: Phase II
Stroke: Phase III

Study Type
Interventional

Study Design
Prevention, Randomized, Single Blind, Active Control, Single Group Assignment, Safety/Efficacy Study

Expected Enrollment
500

Study Start
February 2005

Primary Outcome Measures

All stroke
Systemic embolism
Cardiovascular death

Secondary Outcome Measures

Technical success
Procedure success
30 day major adverse event (MAE)
Left atrial appendage (LAA) coverage

Eligibility

Ages Eligible for Study
18 years and above

Genders Eligible for Study
Both

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)
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%

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