Tests a heart device that closes the left atrial appendage to prevent stroke
Tests a device closing a heart pouch in adults with atrial fibrillation.
Plain-language title generated from the registry record
Registry title: The Fourth Left Atrial Appendage Occlusion Study
Key facts
- Where
- Aarhus, Copenhagen, Esbjerg, Hjørring, Odense C, and Viborg, DenmarkSee the 6 sites
Where in Denmark
- Aarhus University Hospital (AUH)Aarhus, DenmarkTaking people
- Rigshospitalet (RH)Copenhagen, DenmarkTaking people
- Esbjerg & Grindsted Hospital - University Hospital of Southern DenmarkEsbjerg, DenmarkTaking people
- North Denmark Regional HospitalHjørring, DenmarkTaking people
- Odense Universitets HospitalOdense C, DenmarkTaking people
- Region Hospital ViborgViborg, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hamilton Health Sciences Corporation
- Trial code
- NCT05963698
- Record updated
- 18 September 2026
- Original description
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.Read full original descriptionShow less
The Fourth Left Atrial Appendage Occlusion Study (LAAOS-4)
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.
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: 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; Individuals being treated with direct thrombin inhibitors; Age < 18 years; Anticipated life-expectancy of < 2 years; Current left atrial appendage thrombus; Planned atrial fibrillation ablation within 90 days of enrollment; Women of childbearing potential unless they agree to employ effective birth control methods throughout the study; Patient unable or willing to give informed consent.