The Fourth Left Atrial Appendage Occlusion Study

Recruiting now · Not applicable

Conditions studied: Atrial Fibrillation, Stroke, Ischemic, Systemic Embolism

In brief

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.

Key facts

Study ID

NCT05963698

Run by

Hamilton Health Sciences Corporation

People needed

4000

Starts

2023-11-30

Expected to finish

2029-12-01

Last updated by the study team

2026-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• (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.

You may not qualify if…

• 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

Where it is running

• Arrhythmia Research Group — Jonesboro, Arkansas, United States (enrolling)
• Memorial Health Services — Fountain Valley, California, United States (enrolling)
• Loma Linda University Health — Loma Linda, California, United States (enrolling)
• Southern California Permanente Medical Group — Pasadena, California, United States (enrolling)
• Sutter Valley Hospitals dba Sutter Institute for Medical Research — Sacramento, California, United States (enrolling)
• JFK Medical Center Limited Partnership d/b/a HCA Florida JFK Hospital — Atlantis, Florida, United States (enrolling)
• St. Vincent's Health System — Jacksonville, Florida, United States (enrolling)
• Largo Medical Center, Inc. d/b/a HCA Florida Largo Medical Center — Largo, Florida, United States (enrolling)
• HCA Florida Ocala Hospital — Ocala, Florida, United States (enrolling)
• The University of South Florida — Tampa, Florida, United States (enrolling)
• Emory University — Atlanta, Georgia, United States (enrolling)
• St Luke's Regional Medical Center, Ltd — Boise, Idaho, United States (enrolling)
• Kootenai Health Inc. — Coeur d'Alene, Idaho, United States (enrolling)
• Northwestern University — Evanston, Illinois, United States (enrolling)
• Cardiovascular Medicine, PLLC and Unity Point Trinity Rock Island — Rock Island, Illinois, United States (enrolling)
• Community Health Network Inc. — Indianapolis, Indiana, United States (enrolling)
• MercyOne Iowa Heart Center — West Des Moines, Iowa, United States (enrolling)
• University of Kansas Medical Center Research Institute, Inc. — Kansas City, Kansas, United States (enrolling)
• Babtist Health Lexington — Lexington, Kentucky, United States (enrolling)
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States (enrolling)
• University of Maryland Baltimore — Baltimore, Maryland, United States (enrolling)
• Lahey Clinic Inc. — Burlington, Massachusetts, United States (enrolling)
• University of Michigan — Ann Arbor, Michigan, United States (enrolling)
• Henry Ford Health System — Detroit, Michigan, United States (enrolling)
• Henry Ford Health System — Detroit, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

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