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 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 (LAA) to trap potential emboli before they exit the LAA.
Phase
Phase II/III
Study Type
Interventional
Study Design
Prevention, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Study Arms
1
Expected Enrollment
1550
Study Start
February 2005
Expected Completion
October 2014
Primary Outcome Measures
- All stroke out to 5 years
- Systemic embolism out to 5 years
- Cardiovascular death out to 5 years
Secondary Outcome Measures
- Technical success
- Procedure success
- 30 day major adverse event (MAE)
- Left atrial appendage (LAA) coverage
- Device Malfunction within 30 days
Eligibility
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)
- 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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