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Assessment of the WATCHMAN™ Device in Patients Unsuitable for Oral Anticoagulation (ASAP-TOO)
The objective for this study is to establish the safety and effectiveness of the WATCHMAN Device for subjects with non-valvular atrial fibrillation who are deemed not suitable for anti-coagulation therapy to reduce the risk of stroke.
- The subject has documented paroxysmal, persistent, permanent or long-term/longstanding persistent non-valvular atrial fibrillation (i.e., the subject has not been diagnosed with rheumatic mitral valvular heart disease)
- The subject has a calculated CHA2DS2-VASc score of 2 or greater
- The subject is deemed by two study physicians to be unsuitable for oral anticoagulation
- The subject is deemed by a study physician to be suitable for the defined protocol pharmacologic regimen of aspirin and clopidogrel therapy following WATCHMAN Closure Device implant