Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT03759418
Status:
COMPLETED
Last Update Posted:
2018-11-30
First Post:
2018-09-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Left Atrial Appendage Ligation Using the Atriclip Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-28', 'studyFirstSubmitDate': '2018-09-10', 'studyFirstSubmitQcDate': '2018-11-28', 'lastUpdatePostDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '12 month follow up with complete exclusion of the Left Atrial Appendage', 'timeFrame': '365 days to complete', 'description': 'The complete exclusion is defined by the lack of fluid communication between the left atrium and left atrial appendage at \\</= 12 months'}], 'secondaryOutcomes': [{'measure': 'Any signs of thrombus in the left atrium', 'timeFrame': '365 days to compete', 'description': 'Any signs of thrombus in the left atrium'}, {'measure': 'Occurrence of Cerebrovascular accident/transient Ischemic Attack', 'timeFrame': '365 days to complete', 'description': 'Occurrence of Cerebrovascular accident/transient ischemic attack postoperative ,/= 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Left Atrial Appendage Ligation', 'Atriclip', 'atrial fibrillation'], 'conditions': ['Left Atrial Appendage Ligation']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All adult patients who had an Atriclip placed to exclude the left atrial appendage.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* Patient is willing to undergo a trans esophageal echocardiogram, or if unable a CT angiogram\n* If female, must be of non-childbearing potential or have a negative pregnancy test within 7 days prior to the procedure\n* Patient is willing to sign an IRB approved Informed Consent\n\nExclusion Criteria:\n\n* Patient did not have an Atriclip device as part of the surgical procedure between 3/2013 and 12/2016.\n* Patient is unwilling or unable to undergo trans esophageal echocardiogram with general anesthesia or a CT angiogram'}, 'identificationModule': {'nctId': 'NCT03759418', 'briefTitle': 'Left Atrial Appendage Ligation Using the Atriclip Device', 'organization': {'class': 'OTHER', 'fullName': 'St. Helena Hospital Coon Joint Replacement Institute'}, 'officialTitle': 'Left Atrial Appendage Ligation Using the Atriclip Device; Single Center Study of Device Safety and Efficacy', 'orgStudyIdInfo': {'id': '005'}}, 'armsInterventionsModule': {'interventions': [{'name': 'exclusion of the left atrial appendage', 'type': 'DEVICE', 'description': '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.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Gansevoort Dunnington, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Helena Hospital Adventist Heart Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Helena Hospital Coon Joint Replacement Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'AtriCure, Inc.', 'class': 'INDUSTRY'}, {'name': 'Adventist Heart and Vascular Institute', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}