Left Atrial Appendage Ligation Using the Atriclip Device; Single Center Study of Device Safety and Efficacy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Primary Endpoint
- 12 month follow up with complete exclusion of the Left Atrial Appendage
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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/
- •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
Time Frame: 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 Outcomes
- Any signs of thrombus in the left atrium(365 days to compete)
- Occurrence of Cerebrovascular accident/transient Ischemic Attack(365 days to complete)