PROTECT AF
WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation
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Status:
Ongoing. Currently recruiting patients.
Purpose:
Comparing the WATCHMAN device to long term warfarin therapy, hoping to demonstrate that the treatment arm is non-inferior to the control arm.
Interventions:
WATCHMAN® device
The WATCHMAN® device is designed to keep harmful sized blood clots that form in the left atrial appendage from entering your blood stream, potentially causing a stroke. It is made of materials that are common to many medical devices. The WATCHMAN device is designed to be permanently placed just behind or at the opening of the left atrial appendage.
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Location(s):
Multiple U.S. locations.
Year Started:
2005
Year Presented:
2009
Design:
Prevention, randomized, single blind, active control, single group assignment, safety/efficacy study.
Inclusion Criteria
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 Criteria
Contraindicated for warfarin, contraindicated for aspirin or clopidogrel (Plavix), 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%.
Primary Outcome:
All stroke; systemic embolism; cardiovascular mortality.
Secondary Outcome:
Technical success; procedure success; 30 day major adverse event (MAE); left atrial appendage (LAA) coverage.
Source of Information:
ClinicalTrials.gov.
Holmes DR, et al "Randomized prospective trial of percutaneous left atrial appendage closure versus warfarin for stroke prevention in atrial fibrillation (PROTECT AF)" ACC 2009; Session 2402.
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Web Links and Publications:
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This information last updated on: 9/28/2009
Reviewed on: 07/13/2009.
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