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8110 Gatehouse Road, Falls Church, VA 22042

Assessment of the WATCHMAN™ Device in Patients Unsuitable for Oral Anticoagulation (ASAP-TOO)

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General Information

Age Group

Adults

Status

Recruiting

Protocol Number

BSC Project #: S2317

Background Information

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 not to be eligible 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.

Offered At

Inova Fairfax Hospital
3300 Gallows Road
Falls Church, VA 22042

Principal Investigator

Matthew Sherwood, MD

Eligibility Information

  • The subject is of legal age to participate in the study
  • The subject has documented paroxysmal, persistent, permanent or longterm/ longstanding persistent non-valvular atrial fibrillation
  • The subject has a calculated CHA2DS2-VASc score of 2 or greater
  • The subject is deemed to be unsuitable for oral anticoagulation
  • The subject is deemed suitable for the pharmacologic regimen of aspirin and clopidogrel following WATCHMAN Closure Device implant
  • The subject or legal representative is able to understand and willing to provide written informed consent to participate in the trial
  • The subject is able and willing to return for required follow-up visits and examinations.

Ineligibility Information

  • The subject is unable or unwilling to return for required follow-up visits
  • The subject had or is planning to have any invasive cardiac procedure within 30 days prior to randomization
  • The subject is planning to have any cardiac or non-cardiac invasive or surgical procedure that would necessitate stopping or modifying the protocol required medication regimen within 90 days after the WATCHMAN Closure Device implant
  • The subject had a prior stroke or TIA within the 30 days prior to randomization
  • The subject had a prior BARC type 3 or 4 bleeding event within the 14 days prior to randomization
  • 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%
  • The subject is of childbearing potential
  • The subject is currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments