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NCT02928497 · ClinicalTrials.gov record · last posted 2026-08-25

Assessment of the WATCHMAN™ Device in Patients Unsuitable for Oral Anticoagulation

Study acronym: ASAP-TOO
StatusTerminated
PhaseNot applicable
Started2017-02-06
View on ClinicalTrials.gov ↗
Why the trial stopped
The enrollment was prematurely terminated on October 15, 2020, with 481 randomized patients. As discussed in the ASAP-TOO Update Meeting held on 16-September-2020 with FDA (Q150603-S001-A005), termination of enrollment was not due to safety concerns
from the ClinicalTrials.gov record
The purpose 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.

Protocol amendment history 2 changes detected by DataLookout

2026-08-26
Reclassified as terminated (was completed)
2026-08-26
Trial terminated: The enrollment was prematurely terminated on October 15, 2020, with 481 randomized patients. As discussed in the ASAP-T...
Trial Details
NCT Number NCT02928497
Lead Sponsor Boston Scientific Corporation
Conditions Stroke
Enrollment 481 participants
Start Date 2017-02-06
Primary Completion 2025-09-23 (estimated)
Study Completion 2025-09-23 (estimated)
Updated on ClinicalTrials.gov 2026-08-25