Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2026-02-28 @ 10:52 PM
Study NCT ID:
NCT02309268
Status:
WITHDRAWN
Last Update Posted:
2015-06-15
First Post:
2014-08-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atrial Appendage Closure Prospective Observational Study
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': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'The principal linvestigator decided not to continue the registry. No patient were enrolled. CLosure to the registry was done October 2014', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-11', 'studyFirstSubmitDate': '2014-08-01', 'studyFirstSubmitQcDate': '2014-12-02', 'lastUpdatePostDateStruct': {'date': '2015-06-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Progress', 'timeFrame': 'At regular visits ( 3 months and annually)', 'description': 'Patients who agree to participate in the registry will allow the Investigators to document their clinical progress and compare their progress to other participants in the study. Meanwhile, the patient will continue to receive routine care from their physician, just as they would if they did not participate in the study. Any information published as a result of this registry, will be kept anonymous. There is no known risk in participating in this study as it is only an observational study.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['left atrial appendage closure'], 'conditions': ['Atrial Fibrillation', 'Left Atrial Appendage Closure']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to monitor how well patients do after surgery for treatment of left atrial appendage (LAA).', 'detailedDescription': 'Patients will be followed in an observational study. We propose to do a single follow-up TEE at 3 to 6 months (this is standard of care) to confirm LAA (left atrial appendage) occlusion. The TEE is not mandatory (this is not a clinical trial), but will be strongly recommended to patients to confirm the efficacy of treatment. This will help confirm whether patients may safely remain off anticoagulation. The risks of TEE are a less than 1 in 1000 risk of death, and a 1% or less risk of a major complication, such as esophageal perforation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients being asked to take part in this study have a heart disorder known as atrial fibrillation (AF) and are poor candidates to take blood thinning drug known as warfarin (Coumadin), and have elected to undergo LARIAT procedure.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Atrial fibrillation\n* Are poor candidates to take warfarin\n* Have elected to undergo a LARIAT procedure\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT02309268', 'acronym': 'LARIAT', 'briefTitle': 'Atrial Appendage Closure Prospective Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'LARIAT: Atrial Appendage Closure Prospective Observational Study', 'orgStudyIdInfo': {'id': 'LARIAT'}}, 'contactsLocationsModule': {'locations': [{'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Medical Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'kenneth A Ellenbogen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}