--- title: Left Atrial Appendage Ligation Using the Atriclip Device nct_id: NCT03759418 overall_status: COMPLETED sponsor: St. Helena Hospital Coon Joint Replacement Institute study_type: OBSERVATIONAL primary_condition: Left Atrial Appendage Ligation canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03759418.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03759418" ct_last_update_post_date: 2018-11-30 last_seen_at: "2026-05-12T06:53:00.985Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Left Atrial Appendage Ligation Using the Atriclip Device **Official Title:** Left Atrial Appendage Ligation Using the Atriclip Device; Single Center Study of Device Safety and Efficacy **NCT ID:** [NCT03759418](https://clinicaltrials.gov/study/NCT03759418) ## Key Facts - **Status:** COMPLETED - **Study Type:** OBSERVATIONAL - **Target Enrollment:** 100 - **Lead Sponsor:** St. Helena Hospital Coon Joint Replacement Institute - **Collaborators:** AtriCure, Inc., Adventist Heart and Vascular Institute - **Conditions:** Left Atrial Appendage Ligation - **Start Date:** 2016-04 - **Completion Date:** 2018-04 - **CT.gov Last Update:** 2018-11-30 ## 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. ## Eligibility - **Minimum age:** 21 Years - **Sex:** ALL - **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 12/2016. * Patient is unwilling or unable to undergo trans esophageal echocardiogram with general anesthesia or a CT angiogram ``` ## Interventions - **exclusion of the left atrial appendage** (DEVICE) — 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. ## 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 \