This trial is active, not recruiting.

Conditions atrial fibrillation, stroke
Treatments watchman device, warfarin
Phase phase 3
Sponsor Boston Scientific Corporation
Start date November 2010
End date January 2013
Trial size 475 participants
Trial identifier NCT01182441, CT1004


This is a prospective, randomized, multicenter study to provide additional information on the safety and efficacy of the WATCHMAN LAA Closure Technology.

The PREVAIL study was amended to initiate a prospective, non-randomized continued access study titled "Continued Access to PREVAIL (CAP2)" to collect additional information on the safety and efficacy of the WATCHMAN LAA closure technology. The study is estimated to enroll an initial cohort of 300 subjects with a maximum of 1500 subjects, at 60 investigational sites in the U.S.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Subjects assigned to receive the WATCHMAN device.
watchman device
WATCHMAN Left Atrial Appendage Closure Technology
(Active Comparator)
Subjects assigned to warfarin therapy.
warfarin Coumadin
Warfarin dosage prescribed by study physician to adequately maintain an INR of 2.0-3.0

Primary Outcomes

Primary Endpoints
time frame: 18 month rates

Secondary Outcomes

Predefined Additional Analyses
time frame: 18 month rates and acute procedure rates

Eligibility Criteria

Male or female participants at least 18 years old.

Key Inclusion Criteria: - 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 Criteria: - 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 Exclusion Criteria: - LVEF < 30% - Existing pericardial effusion > 2mm - High risk PFO - Significant mitral valve stenosis - Complex atheroma with mobile plaque of the descending aorta and/or aortic arch - Cardiac tumor

Additional Information

Official title Prospective Randomized Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy
Principal investigator David R. Holmes, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Boston Scientific Corporation.