The Fourth Left Atrial Appendage Occlusion Study
NCT05963698 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4000
Last updated 2026-03-12
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
- Atrial Fibrillation
- Stroke, Ischemic
- Systemic Embolism
Interventions
- DEVICE
-
WATCHMAN device
Participants will undergo endovascular left atrial appendage occlusion with the WATCHMAN device
Sponsors & Collaborators
- 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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