VClip Post-Market Study

Study Overview
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Brief Summary
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Retrospective-prospective, multi-center, non-randomized, unblinded, post-market study to evaluate the long-term performance and safety of AtriClip® FLEX-V LAA and PRO•V LAA Exclusion devices for exclusion of the left atrial appendage of the heart during concomitant cardiac procedures.

Official Title
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Long-term Follow-up on LAA Exclusion Using AtriClip

Conditions
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Left Atrial Appendage Absent

Intervention / Treatment
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* Device: AtriClip


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is greater than or equal to 18 years of age. Subject who received the AtriClip FLEX-V or PRO•V implant during a non-emergent cardiac surgical procedure Subject is willing and able to provide written informed consent Subject is willing and able to return for scheduled follow-up visit and imaging (CTA or TEE) Exclusion Criteria: Inability, unwillingness, or contraindication to undergo TEE or CTA imaging Subjects who are pregnant or breast feeding Subjects with active COVID-19 infection

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AtriClip group<br> | Device: AtriClip<br>* Received AtriClip for exclusion of left atrial appendage during concomitant cardiac procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Performance Endpoint | Left Atrial Appendage exclusion defined as absence of residual communication (≤3 mm residual communication with LAA) between the left atrium (LA) and the LAA as assessed by CTA or TEE imaging at the last follow-up visit. The images will be reviewed by an independent core lab using a standardized imaging protocol. | 12-months or greater post-procedure | 
| Primary Safety Endpoint | Incidence of the following serious adverse events within 30-days, if related tot he device and/or implant procedure: Death Ischemic Stroke Transient Ischemic Attack Systemic Embolism Hemorrhagic Stroke Major Bleeding (BARC 3 and above) Surgical site infection Pericardial effusion requiring intervention Clinical diagnosis of myocardial infarction | 30-days post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance | A residual LAA neck ≤10 mm as assessed by CTA or TEE imaging at the last follow-up visit | 12-months or greater post-procedure | 
| Long-term thromboembolic events | Incidence of thromboembolic events (ischemic stroke, TIA, systemic embolism) of any cause through the last follow-up visit. | 12-months or greater post-procedure | 
| Device and Procedure long-term Safety | Device or procedure related SAEs through the last follow-up visit | 12-months or greater post-procedure |