Left Atrial Appendage Ligation Using the Atriclip Device

Study Overview
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Brief Summary
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The purpose of the study is to collect data regarding ligation of the left atrial appendage at least 12 months after surgery for patients that had exclusion of the left atrial appendage as a primary minimally invasive procedure or in conjunction with other open cardiac or minimally invasive cardiac procedures.

Detailed Description
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The purpose of this study is to collect data regarding ligation of the left atrial appendage at least 12 months after surgery for patients that had exclusion of the left atrial appendage as a primary minimally invasive procedure or in conjunction with other open cardiac or minimally invasive cardiac procedures. The patient will undergo a transesophageal echocardiogram (TEE) to collect the following data: Left Ventricular Ejection Fraction; Left Atrial diameter size; confirmation of Left Atrial Appendage exclusion defined by the absence of left atrial to LAA (left atrial appendage) communication measured in millimeters and absence of LAA pocket measured in millimeters; presence of thrombus in left atrium.

Official Title
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Left Atrial Appendage Ligation Using the Atriclip Device; Single Center Study of Device Safety and Efficacy

Conditions
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Left Atrial Appendage Ligation

Intervention / Treatment
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* Device: exclusion of the left atrial appendage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All adult patient who had a heart procedure where an Atriclip device was deployed as the primary or secondary procedure between 3/2013-12/20/2016 Patient is willing to undergo a trans esophageal echocardiogram, or if unable a CT angiogram If female, must be of non-childbearing potential or have a negative pregnancy test within 7 days prior to the procedure Patient is willing to sign an IRB approved Informed Consent Exclusion Criteria: Patient did not have an Atriclip device as part of the surgical procedure between 3/2013 and 12/2016. Patient is unwilling or unable to undergo trans esophageal echocardiogram with general anesthesia or a CT angiogram

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: exclusion of the left atrial appendage|A trans esophageal echocardiogram will be performed to assess the Atriclip device in the closure of the left atrial appendage in patients that had surgery at least 12 months ago.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12 month follow up with complete exclusion of the Left Atrial Appendage | The complete exclusion is defined by the lack of fluid communication between the left atrium and left atrial appendage at </= 12 months | 365 days to complete | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any signs of thrombus in the left atrium | Any signs of thrombus in the left atrium | 365 days to compete | 
| Occurrence of Cerebrovascular accident/transient Ischemic Attack | Occurrence of Cerebrovascular accident/transient ischemic attack postoperative ,/= 12 months | 365 days to complete | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Left Atrial Appendage Ligation, Atriclip, atrial fibrillation