Left Atrial Appendage Ligation Using the Atriclip Device

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

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.

Study Overview

• Status: Completed
• Conditions: Left Atrial Appendage Ligation
• Intervention / Treatment: Device: exclusion of the left atrial appendage

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 Type: Observational
• Enrollment (Actual): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All adult patients who had an Atriclip placed to exclude the left atrial appendage.

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: St. Helena Hospital Coon Joint Replacement Institute
• Collaborators: AtriCure, Inc.; Adventist Heart and Vascular Institute
• Investigators: Principal Investigator: Gansevoort Dunnington, MD, St. Helena Hospital Adventist Heart Institute

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (ACTUAL): April 1, 2018
• Study Completion (ACTUAL): April 1, 2018

Study Registration Dates

• First Submitted: September 10, 2018
• First Submitted That Met QC Criteria: November 28, 2018
• First Posted (ACTUAL): November 30, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 30, 2018
• Last Update Submitted That Met QC Criteria: November 28, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: atrial fibrillation; Left Atrial Appendage Ligation; Atriclip
• Other Study ID Numbers: 005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO