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8110 Gatehouse Road, Falls Church, VA 22042

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

General Information

Age Group

Adult

Status

Active

Protocol Number

NCT02928497

Background Information

The ASAP-TOO study is a prospective, randomized, multi-center, global investigation to establish the safety and effectiveness of WATCHMAN for subjects with non-valvular atrial fibrillation who are deemed not suitable for anti-coagulation therapy to reduce the risk of stroke. Subjects are randomized in a ratio of 2 device to 1 control to receive the WATCHMAN LAA closure device or the control treatment of single antiplatelet medication or no medication at the discretion of the study physician.

Offered At

Inova Fairfax Hospital
3300 Gallows Road
Falls Church, VA 22042

Principal Investigator

Matthew Sherwood, MD

Eligibility Information

  • Subjects who are at least 18 years of age at the time of informed consent
  • Documented paroxysmal, permanent or long-term/ longstanding persistent non –valvular atrial fibrillation
  • The subject has a calculated CHA2DS-VAScscore of 2 or greater
  • The subject is deemed by two study physicians to be unsuitable for oral anticoagulation

Ineligibility Information

  • The subject had a prior stroke or TIA within 30 days prior to randomization.
  • The subject had a prior BARC type 3 or 4 bleeding event within 14 days prior to randomization.