Status:
RECRUITING
The Fourth Left Atrial Appendage Occlusion Study
Lead Sponsor:
Hamilton Health Sciences Corporation
Collaborating Sponsors:
McMaster University
Population Health Research Institute
Conditions:
Atrial Fibrillation
Stroke, Ischemic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
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 ...
Eligibility Criteria
Inclusion
- (a) Persistent or permanent atrial fibrillation OR (b) Paroxysmal atrial fibrillation in participants with a history of ischemic stroke or systemic embolism
- Increased risk of stroke, defined as a CHA2DS2-VASc stroke risk score of ≥ 4. \[Note: the acronym CHA2DS2-VASc stands for congestive heart failure, hypertension, age ≥75 (doubled), diabetes, stroke (doubled), vascular disease, age 65 to 74 and sex category (female).\]
- 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.
Exclusion
- Age \< 18 years
- Current left atrial appendage thrombus
- Prior left atrial appendage occlusion or removal (surgical or percutaneous)
- Prior percutaneous atrial septal defect or patent foramen ovale closure
- Prior atrial fibrillation ablation unless evidence of recurrent qualifying atrial fibrillation present at least 30 days following ablation
- Planned atrial fibrillation ablation within 90 days of enrollment
- Individuals being treated with direct thrombin inhibitors
- Women of childbearing potential unless they agree to employ effective birth control methods throughout the study
- Anticipated life-expectancy of \< 2 years
- Patient unable or willing to give informed consent
Key Trial Info
Start Date :
November 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
4000 Patients enrolled
Trial Details
Trial ID
NCT05963698
Start Date
November 30 2023
End Date
December 1 2029
Last Update
December 16 2025
Active Locations (108)
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1
Affinity Hospital dba Grandview Medical Center
Birmingham, Alabama, United States, 35243
2
Arrhythmia Research Group
Jonesboro, Arkansas, United States, 72401
3
Memorial Health Services
Fountain Valley, California, United States, 92708
4
Loma Linda University Health
Loma Linda, California, United States, 92354