Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2026-02-21 @ 10:25 AM
Study NCT ID:
NCT04108169
Status:
UNKNOWN
Last Update Posted:
2019-09-30
First Post:
2019-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association Between S-LAAO and Adverse Cardiovascular Events Among Patients Undergoing Coronary Artery Bypass Grafting.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-27', 'studyFirstSubmitDate': '2019-09-26', 'studyFirstSubmitQcDate': '2019-09-27', 'lastUpdatePostDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause death', 'timeFrame': '3 year after discharge (These data is collected during follow-up visit at in-hospital)'}], 'secondaryOutcomes': [{'measure': 'Atrial fibrillation', 'timeFrame': '3 year after discharge (These data is collected during follow-up visit at in-hospital)'}, {'measure': 'Composite of ischemic stroke, thromboembolism and all death', 'timeFrame': '3 year after discharge (These data is collected during follow-up visit at in-hospital)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronary artery bypass graft', 'Left Atrial Appendage Occlusion', 'stroke', 'prevention'], 'conditions': ['Heart Surgery']}, 'descriptionModule': {'briefSummary': 'This is a prospective, single-center, randomized, active controlled, clinical trail to assess the efficacy and safety of surgical closure of left atrial appendage (LAA) in patients undergoing coronary artery bypass graft.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject undergoing coronary artery bypass grafting according to clinical indications;\n2. Age is more than 18 and less than 80 years old;\n3. Male and non pregnancy female;\n4. Subject understands study requirements and agrees to sign an informed consent from prior to study procedures.\n\nExclusion Criteria:\n\n1. Pregnancy female;\n2. Participate in other clinical trial in the last 1 month.\n3. Subject doesn't agree to sign an informed consent from prior to study procedures.\n4. Subject undergoing repeat CABG, concomitant valve or other cardiac surgery.\n5. New York Heart Association (NYHA) Class IV heart failure."}, 'identificationModule': {'nctId': 'NCT04108169', 'briefTitle': 'Association Between S-LAAO and Adverse Cardiovascular Events Among Patients Undergoing Coronary Artery Bypass Grafting.', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Institute of Heart, Lung and Blood Vessel Diseases'}, 'officialTitle': 'A Chinese Registry to Evaluate the Association of Surgical Left Atrial Appendage Occlusion vs No Receipt of S-LAAO With Adverse Cardiovascular Events Among Petients Undergoing Coronary Artery Bypass Grafting.', 'orgStudyIdInfo': {'id': '20190926'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator', 'interventionNames': ['Procedure: Left atrial appendage occlusion surgery']}, {'type': 'NO_INTERVENTION', 'label': 'Sham Comparator'}], 'interventions': [{'name': 'Left atrial appendage occlusion surgery', 'type': 'PROCEDURE', 'description': 'CABG according to indications in the current guidelines on myocardial revascularization including surgical closure of left atrial appendage', 'armGroupLabels': ['Active Comparator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'ke-xu Yang', 'role': 'CONTACT', 'email': 'EC@anzhenGCP.com', 'phone': '86-010-64426153'}], 'facility': 'Beijing Anzhen Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yulin Li, PHD', 'role': 'CONTACT', 'email': 'lyllyl_1111@163.com', 'phone': '86-010-64426153'}, {'name': 'Ping Li, PHD', 'role': 'CONTACT', 'email': '13520112185@163.com'}], 'overallOfficials': [{'name': 'Ping Li, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Beijing Anzhen Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Institute of Heart, Lung and Blood Vessel Diseases', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}