ASAP II Assessment of the WATCHMAN™ Device
Assessment of the WATCHMAN™ device in patients unsuitable for oral anticoagulation.
Protocol Description
The primary objective of this study is to establish the safety and effectiveness of the WATCHMAN™ left atrial appendage closure (LAAC) device, including the post-implant medication regimen, for subjects with non-valvular atrial fibrillation who are deemed ineligible for anti-coagulation therapy to reduce the risk of stroke. The device is intended to reduce the risk of thromboembolic ischemic stroke and systemic embolism. Enrollment has closed.
Eligibility Criteria
Inclusion Criteria
- The subject has documented paroxysmal, persistent, permanent or longterm/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.
Exclusion Criteria
- The subject had a prior BARC type 3 or 4 bleeding event within the 14 days prior to randomization. Lack of resolution of related clinical sequelae, or planned and pending interventions to resolve bleeding/bleeding source, are a further exclusion regardless of timing of the bleeding event.
- The subject has a history of atrial septal repair or has an ASD/PFO device
- The subject has an implanted mechanical valve prosthesis in any position
- The subject suffers from New York Heart Association Class IV Congestive Heart Failure
- The subject has LVEF <30%.
Principal Investigator
Jason Foerst, MD, Medical director of the Structural Heart and Valve Center at Carilion Clinic and an assistant professor of Medicine at the Virginia Tech Carilion School of Medicine.
