WATCHMAN Device for Stroke Prevention in Atrial Fibrillation

(ASAP-TOO Trial)

Recruiting in Palo Alto (17 mi)

+96 other locations

Overseen by Vivek Reddy, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Boston Scientific Corporation

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Jacqueline Saw, MD

Principal Investigator

Vancouver General Hospital

Vivek Reddy, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Maurice Buchbinder, MD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for adults with non-valvular atrial fibrillation who can't take blood thinners. They must be able to take aspirin and clopidogrel after getting the WATCHMAN device implanted, willing to consent, and commit to follow-up visits. Excluded are those needing certain surgeries soon, with severe heart issues or bleeding disorders, pregnant women, or those in conflicting studies.

Inclusion Criteria

I am legally old enough to participate in this study according to my local laws.

I can and will come back for all needed follow-ups.

Two doctors agree I can't take blood thinners by mouth.

Exclusion Criteria

My heart's pumping ability is significantly reduced.

The subject has a life expectancy of less than two years

I plan to undergo a surgery or procedure within 3 months after getting a WATCHMAN device.

Treatment Details

Interventions

• Single Antiplatelet Therapy or No Therapy (Control) (Drug)
• WATCHMAN LAAC Device Implant (Device)

Trial Overview The study tests the WATCHMAN Left Atrial Appendage Closure Device's safety and effectiveness in reducing stroke risk without standard blood thinners. Participants will either receive this implant plus a special medication regimen or no therapy as control.

Participant Groups

Group I: WATCHMAN (Device) Experimental Treatment 1 Intervention

WATCHMAN LAAC Device implant including modified post-implant drug regimen.

Group II: Control Active Control 1 Intervention

Single antiplatelet therapy or no therapy (Control) at the discretion of the study physician for the duration of the trial.

Who Is Running the Clinical Trial?

Boston Scientific Corporation

Lead Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology