Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy "PREVAIL"

Active, not recruiting

Phase 3 Results N/A

Update History

27 Sep '12
The Summary of Purpose was updated.
New
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.
Old
This is a prospective, randomized, multicenter study to provide additional information on the safety and efficacy of the WATCHMAN LAA Closure Technology.
5 Aug '12
A location was updated in Gilbert.
New
The overall status was removed for Mercy Gilbert Medical Center.
A location was updated in Scottsdale.
New
The overall status was removed for Arizona Heart Rhythm Research Center.
A location was updated in La Jolla.
New
The overall status was removed for Foundation for Cardiovascular Medicine.
A location was updated in La Jolla.
New
The overall status was removed for Scripps Green.
A location was updated in Los Angeles.
New
The overall status was removed for Cedars-Sinai Medical Center.
A location was updated in Orange County.
New
The overall status was removed for Orange County Heart.
A location was updated in Santa Monica.
New
The overall status was removed for St. John's Hospital / Pacific Heart.
A location was updated in Atlantis.
New
The overall status was removed for Palm Beach Heart Research.
A location was updated in Miami.
New
The overall status was removed for Baptist Hospital of Miami.
A location was updated in Orlando.
New
The overall status was removed for Florida Hospital.
A location was updated in Atlanta.
New
The overall status was removed for Emory University.
A location was updated in Evanston.
New
The overall status was removed for North Shore University.
A location was updated in Des Moines.
New
The overall status was removed for Iowa Heart Center.
A location was updated in Lexington.
New
The overall status was removed for Central Baptist Hospital.
A location was updated in Boston.
New
The overall status was removed for Massachusetts General Hospital.
A location was updated in Burlington.
New
The overall status was removed for Lahey Clinic.
A location was updated in Ann Arbor.
New
The overall status was removed for University of Michigan Medical Center.
A location was updated in Royal Oak.
New
The overall status was removed for William Beaumont.
A location was updated in Minneapolis.
New
The overall status was removed for Abbott Northwestern Hospital.
A location was updated in Rochester.
New
The overall status was removed for Mayo Clinic.
A location was updated in Tupelo.
New
The overall status was removed for Cardiology Associates of N. Mississippi.
A location was updated in Kansas City.
New
The overall status was removed for St. Luke's Hospital.
A location was updated in St. Louis.
New
The overall status was removed for St. John's Mercy.
A location was updated in Lincoln.
New
The overall status was removed for Bryan LGH.
A location was updated in Englewood.
New
The overall status was removed for Englewood Hospital and Medical Center.
A location was updated in New York.
New
The overall status was removed for New York University Medical Center.
A location was updated in New York.
New
The overall status was removed for Mt. Sinai School of Medicine.
A location was updated in Charlotte.
New
The overall status was removed for Carolinas Medical Center.
A location was updated in Cincinnati.
New
The overall status was removed for Lindner Clinical Trial Center.
A location was updated in Cleveland.
New
The overall status was removed for Cleveland Clinic.
A location was updated in Philadelphia.
New
The overall status was removed for Hospital of the University of Pennsylvania.
A location was updated in Wormleysburg.
New
The overall status was removed for Moffitt Heart & Vascular.
A location was updated in Nashville.
New
The overall status was removed for St. Thomas Research Institute.
A location was updated in Austin.
New
The overall status was removed for Texas Cardiac Arrhythmia.
A location was updated in Dallas.
New
The overall status was removed for Baylor Research Institute.
A location was updated in Houston.
New
The overall status was removed for Methodist Hospital.
A location was updated in Salt Lake City.
New
The overall status was removed for Intermountain Medical Center.
A location was updated in Burlington.
New
The overall status was removed for Fletcher Allen.
A location was updated in Seattle.
New
The overall status was removed for Swedish Medical Center.
A location was updated in Milwaukee.
New
The overall status was removed for St. Luke's Hospital.
21 Apr '12
A location was updated in Rochester.
New
The overall status was removed for Mayo Clinic.
A location was updated in Philadelphia.
New
The overall status was removed for Hospital of the University of Pennsylvania.
6 Oct '11
The eligibility criteria were updated.
New
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
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