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Device

WATCHMAN Device for Stroke Prevention in Atrial Fibrillation (ASAP-TOO Trial)

N/A
Waitlist Available
Led By Jacqueline Saw, MD
Research Sponsored by Boston Scientific Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The subject or legal representative is able to understand and willing to provide written informed consent to participate in the trial
The subject has documented paroxysmal, persistent, permanent or long-term/longstanding persistent non-valvular atrial fibrillation (i.e., the subject has not been diagnosed with rheumatic mitral valvular heart disease)
Must not have
The subject has LVEF < 30%
The subject is planning to have any cardiac or non-cardiac invasive or surgical procedure that would necessitate stopping or modifying the protocol required medication regimen within 90 days after the WATCHMAN Closure Device implant (e.g., cardioversion, ablation, cataract surgery)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new method to reduce the risk of stroke for people with atrial fibrillation who can't take blood thinners.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects from the WATCHMAN device may include discomfort at the implant site, bleeding complications, possible allergic reactions to device materials or medications post-implant like aspirin and clopidogrel.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can understand and am willing to sign the consent form.
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I have a type of irregular heartbeat not caused by a heart valve issue.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My heart's pumping ability is significantly reduced.
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I plan to undergo a surgery or procedure within 3 months after getting a WATCHMAN device.
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I have a condition that makes my blood clot more than normal.
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I have had or plan to have a heart procedure within the last 30 days.
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I have the most severe form of heart failure.
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I haven't had severe bleeding or unresolved issues from bleeding in the last 14 days.
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I cannot or do not want to come back for needed follow-ups.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary 7-Day Device/Procedural Safety Endpoint
Primary Efficacy Endpoint - time to first event of ischemic stroke or systemic embolism.
Secondary study objectives
Secondary Endpoint - Composite of All Stroke and Cardiovascular or Unknown Death
Hemorrhage

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: WATCHMAN (Device)Experimental Treatment1 Intervention
WATCHMAN LAAC Device implant including modified post-implant drug regimen.
Group II: ControlActive Control1 Intervention
Single antiplatelet therapy or no therapy (Control) at the discretion of the study physician for the duration of the trial.

Find a Location

Who is running the clinical trial?

Boston Scientific CorporationLead Sponsor
744 Previous Clinical Trials
857,342 Total Patients Enrolled
11 Trials studying Stroke
11,358 Patients Enrolled for Stroke
Jacqueline Saw, MDPrincipal InvestigatorVancouver General Hospital
4 Previous Clinical Trials
4,010 Total Patients Enrolled
Vivek Reddy, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
34 Previous Clinical Trials
12,663 Total Patients Enrolled
3 Trials studying Stroke
4,755 Patients Enrolled for Stroke

Media Library

WATCHMAN LAAC Device Implant (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02928497 — N/A
~55 spots leftby Dec 2025
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