ASAP TOO, Version AA
Research type
Research Study
Full title
Assessment of the WATCHMAN Device in Patients Unsuitable for Oral Anticoagulation
IRAS ID
222284
Contact name
Tim Betts
Contact email
Sponsor organisation
Boston Scientific International SA
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 9 months, 16 days
Research summary
The ASAP TOO study is designed to assess the safety and effectiveness of the WATCHMAN Left Atrial Appendage Closure (LAAC) Device including the post-implant medication regimen for participants 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.
The Watchman LAA closure device is currently CE marked for those who are eligible for anticoagulation therapy, this study aims to include those who are at increased risk of stroke but are deemed by their physicians to be unsuitable for oral anticoagulation therapy.
Up to 888 randomized participants will be enrolled in this study over 100 global investigational sites. Eligible participants will be randomized 2:1 to receive the WATCHMAN device to control (single antiplatelet therapy or no therapy).Device Group participants will undergo an implant procedure and both Device Group and Control Group participants will have follow-up visits at: 3, 6, and 12 months and then every 6 months through 60 months. Duration of the individual in the study is expected to be approximately 5 years.
The primary effectiveness endpoint is the time to first occurrence of ischemic stroke or systemic embolism. The primary safety endpoint is the occurrence of all-cause death, ischemic stroke, systemic embolism, or device/procedure related events.REC name
London - Surrey Research Ethics Committee
REC reference
17/LO/0961
Date of REC Opinion
16 Nov 2017
REC opinion
Further Information Favourable Opinion