The Fourth Left Atrial Appendage Occlusion Study

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join 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 be able to join 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 this trial is running

• Affinity Hospital dba Grandview Medical Center, Birmingham, Alabama, United States
• Arrhythmia Research Group, Jonesboro, Arkansas, United States
• Memorial Health Services, Fountain Valley, California, United States
• Loma Linda University Health, Loma Linda, California, United States
• Southern California Permanente Medical Group, Pasadena, California, United States
• Sutter Valley Hospitals dba Sutter Institute for Medical Research, Sacramento, California, United States
• JFK Medical Center Limited Partnership d/b/a HCA Florida JFK Hospital, Atlantis, Florida, United States
• St. Vincent's Health System, Jacksonville, Florida, United States
• Largo Medical Center, Inc. d/b/a HCA Florida Largo Medical Center, Largo, Florida, United States
• HCA Florida Ocala Hospital, Ocala, Florida, United States
• The University of South Florida, Tampa, Florida, United States
• Emory University, Atlanta, Georgia, United States

+ 128 more sites.

Who to contact

Program Director · 905-521-2100 · LAAOS-4@phri.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05963698.