Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy (PREVAIL)
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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.
Condition | Intervention | Phase |
---|---|---|
Atrial Fibrillation Stroke |
Device: WATCHMAN Device Drug: Warfarin |
Phase 3 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | Prospective Randomized Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy |
- Primary Efficacy Endpoint [ Time Frame: 6-Months ] [ Designated as safety issue: Yes ]The occurrence of stroke, cardiovascular death and systemic embolism.
Estimated Enrollment: | 475 |
Study Start Date: | November 2010 |
Estimated Study Completion Date: | June 2017 |
Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: WATCHMAN
Subjects assigned to receive the WATCHMAN device.
|
Device: WATCHMAN Device
WATCHMAN Left Atrial Appendage Closure Technology
|
Active Comparator: Warfarin
Subjects assigned to warfarin therapy.
|
Drug: Warfarin
Warfarin dosage prescribed by study physician to adequately maintain an INR of 2.0-3.0
Other Name: Coumadin
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
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Principal Investigator: | David R. Holmes, M.D. | Mayo Clinic |
Principal Investigator: | Vivek Y. Reddy, M.D. | Mount Sinai School of Medicine |
No publications provided
Responsible Party: | Atritech |
ClinicalTrials.gov Identifier: | NCT01182441 History of Changes |
Other Study ID Numbers: | CT1004 |
Study First Received: | August 12, 2010 |
Last Updated: | September 24, 2012 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by Atritech:
atrial fibrillation stroke TIA |
trans ischemic attack warfarin Coumadin |
Additional relevant MeSH terms:
Atrial Fibrillation Stroke Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases Warfarin Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on October 17, 2012