Status:
COMPLETED
WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Atrial Fibrillation
Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 co...
Detailed Description
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.
Eligibility Criteria
Inclusion
- 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
- 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%
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT00129545
Start Date
February 1 2005
End Date
May 1 2014
Last Update
May 15 2015
Active Locations (62)
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1
Advanced Cardiac Specialists
Gilbert, Arizona, United States, 85233
2
Arizona Arrhythmia
Scottsdale, Arizona, United States, 85251
3
Foundation for Cardiovascular Medicine
La Jolla, California, United States, 92037
4
Los Angeles Cardiology Associates
Los Angeles, California, United States, 90017