The Fourth Left Atrial Appendage Occlusion Study

Not Applicable

Recruiting

• Conditions: Atrial Fibrillation; Stroke, Ischemic; Systemic Embolism

• Registration Number: NCT05963698
• Lead Sponsor: Hamilton Health Sciences Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-7-5
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

Inclusion Criteria:<br><br> 1. (a) Persistent or permanent atrial fibrillation OR (b) Paroxysmal atrial<br> fibrillation in participants with a history of ischemic stroke or systemic embolism<br><br> 2. Increased risk of stroke, defined as a CHA2DS2-VASc stroke risk score of = 4. [Note:<br> the acronym CHA2DS2-VASc stands for congestive heart failure, hypertension, age =75<br> (doubled), diabetes, stroke (doubled), vascular disease, age 65 to 74 and sex<br> category (female).]<br><br> 3. Treatment with oral anticoagulants (Vitamin K agonist or factor Xa inhibitor) for at<br> least 90 days prior to enrollment, AND no documented plan to discontinue treatment<br> with oral anticoagulants for the expected duration of the trial.<br><br>Exclusion Criteria:<br><br> 1. Age < 18 years<br><br> 2. Current left atrial appendage thrombus<br><br> 3. Prior left atrial appendage occlusion or removal (surgical or percutaneous)<br><br> 4. Prior percutaneous atrial septal defect or patent foramen ovale closure<br><br> 5. Prior atrial fibrillation ablation unless evidence of recurrent qualifying atrial<br> fibrillation present at least 30 days following ablation<br><br> 6. Planned atrial fibrillation ablation within 90 days of enrollment<br><br> 7. Individuals being treated with direct thrombin inhibitors<br><br> 8. Women of childbearing potential unless they agree to employ effective birth control<br> methods throughout the study<br><br> 9. Anticipated life-expectancy of < 2 years<br><br> 10. Patient unable or willing to give informed consent

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ischemic stroke or systemic embolism

Secondary Outcome Measures

Name	Time	Method
All-cause stroke or systemic embolism;All-cause stroke, systemic embolism, or transient ischemic attack (TIA);Montreal Cognitive Assessment (MoCA) Score;New disabling ischemic strokes;Cardiovascular mortality;All-cause mortality