Coronary Artery Disease - CAP
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Trial Sponsor
Atritech
Principal Investigator
Gregory Mishkel, MD
Trial Name
WATCHMAN® Left Atrial Appendage System
Continued Access PROTECT AF Registry CAP Registry
Purpose
This study was initially a multi-center, prospective, randomized study, stratified by center, comparing the WATCHMAN device to long term warfarin (coumadin) 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 (registry).
Details
The WATCHMAN device is designed to be permanently implanted distal to the ostium of the left atrial appendage which is located within the heart (LAA) to trap potential emboli (blood clots) before they exit the LAA and go to other parts of the body.
Ages Eligible for Study
18 years or older
Genders Eligible for Study
Both
Inclusion Criteria
- Patient has paroxysmal, persistent or permanent non-valvular atrial fibrillation (AF) – irregular heart beat
- Eligible for long term warfarin (coumadin a blood thinning medication)
- 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
- Subject cannot take warfarin
- Subject cannot take 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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