Status:
COMPLETED
Evaluation of the WATCHMAN Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Atrial Fibrillation
Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This was a prospective, randomized, multicenter study to provide additional information on the safety and efficacy of the WATCHMAN LAA Closure Technology. The purpose of the PREVAIL study was to confi...
Eligibility Criteria
Inclusion
- Key
- Paroxysmal, persistent or permanent non-valvular AF
- Eligible for long-term warfarin therapy
- Eligible to come off warfarin therapy
- Calculated CHADS2 score of 2 or greater. Also patients with a CHADS2 score of 1 may be included if any of the following apply:
- Female age 75 or older
- Baseline LVEF ≥ 30 and \< 35%
- Aged 65-74 and has diabetes or coronary artery disease
- Aged 65 or greater and has congestive heart failure
- Key
Exclusion
- Contraindicated/allergic to aspirin
- Indicated for clopidogrel therapy or has taken clopidogrel within 7 days prior to enrollment
- History of atrial septal repair or has an ASD/PFO device
- Implanted mechanical valve prosthesis
- NYHA Class IV CHF
- Resting heart rate \> 110 bpm
- Participated previously in the PROTECT AF or CAP Registry studies
- Key Echo
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2017
Estimated Enrollment :
407 Patients enrolled
Trial Details
Trial ID
NCT01182441
Start Date
November 1 2010
End Date
November 1 2017
Last Update
July 26 2018
Active Locations (41)
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1
Mercy Gilbert Medical Center
Gilbert, Arizona, United States, 85297
2
Arizona Heart Rhythm Research Center
Scottsdale, Arizona, United States, 85251
3
Foundation for Cardiovascular Medicine
La Jolla, California, United States, 92037
4
Scripps Green
La Jolla, California, United States, 92037