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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

LAAOS-4 Trial 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.Check my eligibility

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.See study design

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).

LAAOS-4 Trial 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.

LAAOS-4 Trial 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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Ischemic stroke or systemic embolism

Secondary outcome measures

All-cause mortality

All-cause stroke or systemic embolism

All-cause stroke, systemic embolism, or transient ischemic attack (TIA)

+3 more

Other outcome measures

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

LAAOS-4 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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hamilton Health Sciences CorporationLead Sponsor

368 Previous Clinical Trials

297,001 Total Patients Enrolled

11 Trials studying Atrial Fibrillation

9,287 Patients Enrolled for Atrial Fibrillation

McMaster UniversityOTHER

884 Previous Clinical Trials

2,594,316 Total Patients Enrolled

10 Trials studying Atrial Fibrillation

6,505 Patients Enrolled for Atrial Fibrillation

Population Health Research InstituteOTHER

155 Previous Clinical Trials

675,912 Total Patients Enrolled

30 Trials studying Atrial Fibrillation

48,302 Patients Enrolled for Atrial Fibrillation

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the present participant count for this medical experiment?

"Indeed, the clinicaltrials.gov registry implies that this medical investigation is actively scouring for participants. The trial was initially shared on November 30th 2023 and has since been updated on December 7th of the same year. 4000 individuals are sought after at one location."

Answered by AI

Are there still openings available to join this research program?

"Affirmative. Clinicaltrials.gov data confirms that the search for participants in this clinical trial is still underway, with an initial post date of November 30th 2023 and a most recent update on December 7th 2023. 4000 patients are sought from 1 location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Fourth Left Atrial Appendage Occlusion Study

2023. "The Fourth Left Atrial Appendage Occlusion Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05963698.

All > Afib > Atrial Fibrillation