NCT02928497

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 481 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The ASAP-TOO study is a prospective, randomized, multi-center, global investigation to establish the safety and effectiveness of the WATCHMAN Device for subjects with non-valvular atrial fibrillation who are deemed not suitable for anti-coagulation therapy to reduce the risk of stroke. Subjects will be randomized in a ratio of 2 Device to 1 Control to receive the WATCHMAN LAA closure device (Device) or the control treatment of single antiplatelet medication or no medication at the discretion of the study physician (Control). All randomized subjects will follow the protocol required tests and assessments at each scheduled follow-up visit.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	WATCHMAN LAAC Device Implant	WATCHMAN LAAC Implant
DRUG	Single Antiplatelet Therapy or No Therapy (Control)	Single Antiplatelet Therapy or No Therapy at the discretion of the study physician.

Timeline

• Start date: 2017-02-06
• Primary completion: 2025-09-23
• Completion: 2025-09-23
• First posted: 2016-10-10
• Last updated: 2026-04-13

Locations

92 sites across 9 countries: United States, Belgium, Canada, Czechia, Denmark, Germany, Italy, Netherlands, United Kingdom

Regulatory

• FDA-regulated device study