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WATCHMAN Device for Atrial Fibrillation (LAAOS-4 Trial)

N/A

Recruiting

Led By Jeff Healey

Research Sponsored by Hamilton Health Sciences Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

(a) Persistent or permanent atrial fibrillation OR (b) Paroxysmal atrial fibrillation in participants with a history of ischemic stroke or systemic embolism

Treatment with oral anticoagulants (Vitamin K agonist or factor Xa inhibitor) for at least 90 days prior to enrollment, AND no documented plan to discontinue treatment with oral anticoagulants for the expected duration of the trial.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the study duration is event-driven. the primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).

Awards & highlights

No Placebo-Only Group

Summary

This trial will study if a device can prevent stroke in people with AFib, despite taking drugs to prevent blood clots. #AFib #stroke

Who is the study for?

This trial is for adults with atrial fibrillation who are at high risk of stroke, even while on blood thinners. They should have a CHA2DS2-VASc score of 4 or more, indicating they're more likely to have a stroke. Participants must be willing to continue their current oral anticoagulant therapy throughout the study.

What is being tested?

The LAAOS-4 study tests if using the WATCHMAN device can prevent strokes or blood clots in people with atrial fibrillation who still face high stroke risks despite taking blood thinners. The device is implanted through a catheter-based procedure.

What are the potential side effects?

Potential side effects may include complications from the implantation procedure like bleeding or infection, and specific risks related to the WATCHMAN device such as device-related thrombosis (blood clots on the device).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have ongoing or occasional atrial fibrillation and have had a stroke or blood clot.

Select...

I have been on blood thinners for at least 3 months and plan to continue.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the study duration is event-driven. the primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the study duration is event-driven. the primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).

This trial's timeline: 3 weeks for screening, Varies for treatment, and the study duration is event-driven. the primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years). for reporting.