Left Atrial Appendage Ligation Using the Atriclip Device

St. Helena Hospital Coon Joint Replacement Institute100 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Left Atrial Appendage Ligation

Interventions

exclusion of the left atrial appendageDEVICE

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.

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 365 days to complete

Secondary Outcomes

Any signs of thrombus in the left atrium

Time frame: 365 days to compete

Occurrence of Cerebrovascular accident/transient Ischemic Attack

Occurrence of Cerebrovascular accident/transient ischemic attack postoperative ,/= 12 months

Time frame: 365 days to complete

Data from ClinicalTrials.gov

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