Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial

Study Overview
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Brief Summary
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This trial is a prospective, randomized, multicenter, multinational, blinded, superiority trial. The objective of this trial is to evaluate the effectiveness of left atrial appendage exclusion (LAAE) for the prevention of ischemic stroke or systemic arterial embolism in subjects undergoing cardiac surgery who have risk factors for atrial fibrillation and ischemic stroke.

Official Title
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Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial

Conditions
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Ischemic Stroke, Systemic Embolism

Intervention / Treatment
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* Device: AtriClip LAA Exclusion System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects ≥ 18 years of age Documentation of any of the following clinical criteria: CHA2DS2-VASc ≥ 4 with age ≥ 65 CHA2DS2-VASc ≥ 4 with significant left atrium enlargement or elevated NT-proBNP CHA2DS2-VASc = 3 with age ≥ 75 CHA2DS2-VASc = 3 with significant left atrium enlargement or elevated NT-proBNP CHA2DS2-VASc score = 2 with age ≥ 65 and significant left atrium enlargement or elevated NT-proBNP Exclusion Criteria: Clinically significant atrial fibrillation or atrial flutter: Anytime in the past and Documented by an electrocardiographic recording and Episode lasting 6 minutes or longer1* Prior procedure involving opening the pericardium or entering the pericardial space Prior LAA occlusion, exclusion, or removal (surgical or percutaneous) Planned cardiac surgical procedure using non-sternotomy approaches o Partial sternotomies will be allowed. Patients whose planned procedure is a heart transplant or implantation of any ventricular assist devices Active endocarditis Active systemic infection at the time of cardiac surgery requiring antibiotics, including known SARS-CoV2 infections regardless of symptoms Known allergy to Nitinol or nickel sensitivity Known medical condition with expected survival of less than 1 year Other comorbidities that in the investigator's opinion make the subject unsuitable candidate to complete the protocol required visits. Current enrollment in an investigation or trial or an investigational devices or investigational drug that would interfere with this trial. Mental impairment or other psychiatric conditions which may not allow the patient to understand the nature, significance, and scope of the trial. Pregnancy Known severe symptomatic carotid disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>LAAE using the AtriClip concomitant to and at the time of planned cardiac surgery | Device: AtriClip LAA Exclusion System<br>* LAAE using the AtriClip concomitant to and at the time of planned cardiac surgery<br>|
| No Intervention: Control<br>No LAAE concomitant to and at the time of planned cardiac surgery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Effectiveness Endpoint | Time to the first occurrence of ischemic stroke or systemic arterial embolism as adjudicated by the Clinical Events Committee (CEC), or any procedure wherein the LAA was excluded, occluded, or amputated following the index procedure. | Common termination point (median follow-up for 5 years) | 
| Primary Safety Endpoint | Occurrence of at least one of the following events assessed through 30 days post index procedure: Pericardial effusion requiring percutaneous or surgical treatment Major bleeding attributable to index surgical procedure Deep sternal wound infection Myocardial infarction | 30 days post index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Powered Secondary Effectiveness endpoint | Time to the first occurrence of ischemic stroke or systemic arterial embolism | Common termination point (median follow-up for 5 years) |