The Fourth Left Atrial Appendage Occlusion Study

Launched by HAMILTON HEALTH SCIENCES CORPORATION · Jul 18, 2023

Keywords

ClinConnect Summary

The Fourth Left Atrial Appendage Occlusion Study (LAAOS-4) is researching whether a specific procedure called catheter-based left atrial appendage occlusion can help prevent strokes and other serious blood clots in people with atrial fibrillation. Atrial fibrillation is a condition where the heart beats irregularly, increasing the risk of strokes. This study is looking for participants aged 65 to 74 who are at high risk of stroke, even while taking blood-thinning medications. To qualify, individuals should have persistent or permanent atrial fibrillation or a history of strokes and must have a certain score indicating their risk.

Participants in this trial will receive the new treatment and will continue their current medication for blood thinning. The study is currently recruiting, and potential participants should not have had certain prior heart procedures or conditions that could affect their eligibility. It’s important for anyone considering joining to discuss their situation with their doctor to see if they meet the criteria and to understand what participation would involve. Overall, this trial aims to find better ways to protect people with atrial fibrillation from strokes.

Gender

ALL

Eligibility criteria

• 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 to discontinue treatment with oral anticoagulants for the expected duration of the trial.
• Exclusion Criteria:
• • 1. Age \< 18 years
• • 2. Current left atrial appendage thrombus
• • 3. Prior left atrial appendage occlusion or removal (surgical or percutaneous)
• • 4. Prior percutaneous atrial septal defect or patent foramen ovale closure
• • 5. Prior atrial fibrillation ablation unless evidence of recurrent qualifying atrial fibrillation present at least 30 days following ablation
• • 6. Planned atrial fibrillation ablation within 90 days of enrollment
• • 7. Individuals being treated with direct thrombin inhibitors
• • 8. Women of childbearing potential unless they agree to employ effective birth control methods throughout the study
• • 9. Anticipated life-expectancy of \< 2 years
• • 10. Patient unable or willing to give informed consent