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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 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.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Ischemic stroke or systemic embolism
Secondary study objectives
All-cause mortality
All-cause stroke or systemic embolism
All-cause stroke, systemic embolism, or transient ischemic attack (TIA)
+3 more
Other study objectives
Device and procedural-related outcomes: Device-related thrombus
Device and procedural-related outcomes: Incomplete left atrial appendage (LAA) closure
Device and procedural-related outcomes: Peri-procedural major bleeding
+4 more

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 deviceExperimental Treatment1 Intervention
Participants will undergo endovascular left atrial appendage occlusion with the WATCHMAN device
Group II: Standard CareActive Control1 Intervention
Participants will receive local, standard medical care

Find a Location

Who is running the clinical trial?

Hamilton Health Sciences CorporationLead Sponsor
377 Previous Clinical Trials
335,929 Total Patients Enrolled
12 Trials studying Atrial Fibrillation
10,157 Patients Enrolled for Atrial Fibrillation
McMaster UniversityOTHER
918 Previous Clinical Trials
2,612,293 Total Patients Enrolled
11 Trials studying Atrial Fibrillation
7,905 Patients Enrolled for Atrial Fibrillation
Population Health Research InstituteOTHER
164 Previous Clinical Trials
714,514 Total Patients Enrolled
33 Trials studying Atrial Fibrillation
51,124 Patients Enrolled for Atrial Fibrillation
Boston Scientific CorporationIndustry Sponsor
746 Previous Clinical Trials
853,989 Total Patients Enrolled
78 Trials studying Atrial Fibrillation
30,497 Patients Enrolled for Atrial Fibrillation
Jeff HealeyPrincipal InvestigatorHamilton Health Sciences Corporation
2 Previous Clinical Trials
951 Total Patients Enrolled
2 Trials studying Atrial Fibrillation
951 Patients Enrolled for Atrial Fibrillation
~2667 spots leftby Sep 2029
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