The Fourth Left Atrial Appendage Occlusion Study

NCT05963698 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4000

Last updated 2026-03-12

No results posted yet for this study

Summary

LAAOS-4 aims to determine if catheter-based endovascular left atrial appendage occlusion prevents ischemic stroke or systemic embolism in participants with atrial fibrillation, who remain at high risk of stroke, despite receiving ongoing treatment with oral anticoagulation.

Conditions

Interventions

DEVICE

WATCHMAN device

Participants will undergo endovascular left atrial appendage occlusion with the WATCHMAN device

Sponsors & Collaborators

  • McMaster University

    collaborator OTHER
  • Population Health Research Institute

    collaborator OTHER
  • Boston Scientific Corporation

    collaborator INDUSTRY
  • Hamilton Health Sciences Corporation

    lead OTHER

Principal Investigators

  • Jeff Healey · Hamilton Health Sciences Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-30
Primary Completion
2029-09-01
Completion
2029-12-01
FDA Device
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Denmark
  • France
  • Germany
  • Italy
  • Netherlands
  • Poland
  • Spain
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05963698 on ClinicalTrials.gov