NCT05963698

The Fourth Left Atrial Appendage Occlusion Study

The Fourth Left Atrial Appendage Occlusion Study (LAAOS-4)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 4,000 (estimated)
• Sponsor: Hamilton Health Sciences Corporation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

LAAOS-4 is a multicentre, prospective, open-label, randomized controlled trial with blinded assessment of endpoints (PROBE) 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

Type	Name	Description
DEVICE	WATCHMAN device	Participants will undergo endovascular left atrial appendage occlusion with the WATCHMAN device

Timeline

• Start date: 2023-11-30
• Primary completion: 2029-09-01
• Completion: 2029-12-01
• First posted: 2023-07-27
• Last updated: 2026-03-12

Locations

127 sites across 11 countries: United States, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated device study