The Fourth Left Atrial Appendage Occlusion Study (LAAOS-4)
Hamilton Health Sciences Corporation
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.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. (a) Persistent or permanent atrial fibrillation OR (b) Paroxysmal atrial fibrillation in participants with a history of ischemic stroke or systemic embolism 2. Increased risk of stroke, defined as a CHA2DS2-VASc stroke risk score of ≥ 4. \[Note: the acronym CHA2DS2-VASc stands for congestive heart failure, hypertension, age ≥75 (doubled), diabetes, stroke (doubled), vascular disease, age 65 to 74 and sex category (female).\] 3. Treatment with oral anticoagulants (Vitamin K agonist or factor Xa inhibitor) for at least 90 days prior to enrollment, AND no documented plan t…
Interventions
- DeviceWATCHMAN device
Participants will undergo endovascular left atrial appendage occlusion with the WATCHMAN device
Locations (127)
- Affinity Hospital dba Grandview Medical CenterBirmingham, Alabama
- Arrhythmia Research GroupJonesboro, Arkansas
- Memorial Health ServicesFountain Valley, California
- Loma Linda University HealthLoma Linda, California
- Southern California Permanente Medical GroupPasadena, California
- Sutter Valley Hospitals dba Sutter Institute for Medical ResearchSacramento, California