Left Atrial Appendage Ligation Using the Atriclip Device

Completed

• Conditions: Left Atrial Appendage Ligation

• Registration Number: NCT03759418
• Lead Sponsor: St. Helena Hospital Coon Joint Replacement Institute

Brief Summary

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

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 Timeline

• Study Start: 2016-04
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Status Verified: 2018-09
• Study First Submitted: 2018-09-10
• Study First Submitted QC: 2018-11-28
• Last Update Submitted: 2018-11-28
• Study First Posted: 2018-11-30
• Last Update Posted: 2018-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
12 month follow up with complete exclusion of the Left Atrial Appendage	365 days to complete	The complete exclusion is defined by the lack of fluid communication between the left atrium and left atrial appendage at \</= 12 months

Secondary Outcome Measures

Name	Time	Method
Any signs of thrombus in the left atrium	365 days to compete	Any signs of thrombus in the left atrium
Occurrence of Cerebrovascular accident/transient Ischemic Attack	365 days to complete	Occurrence of Cerebrovascular accident/transient ischemic attack postoperative ,/= 12 months