Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-26 @ 12:01 AM
Study NCT ID:
NCT01113294
Status:
UNKNOWN
Last Update Posted:
2010-04-29
First Post:
2010-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of Catheter Ablation for Atrial Fibrillation
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017115', 'term': 'Catheter Ablation'}], 'ancestors': [{'id': 'D000078703', 'term': 'Radiofrequency Ablation'}, {'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2040}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-04-27', 'studyFirstSubmitDate': '2010-04-21', 'studyFirstSubmitQcDate': '2010-04-27', 'lastUpdatePostDateStruct': {'date': '2010-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'recurrence of atrial arrhythmias (AF, AFL, AT)', 'timeFrame': '1 month'}, {'measure': 'recurrence of atrial arrhythmias (AF, AFL, AT)', 'timeFrame': '3 month'}, {'measure': 'recurrence of atrial arrhythmias (AF, AFL, AT)', 'timeFrame': '6 month'}, {'measure': 'recurrence of atrial arrhythmias (AF, AFL, AT)', 'timeFrame': '12 month'}], 'secondaryOutcomes': [{'measure': 'Number of participants with all-cause death', 'timeFrame': '1 month'}, {'measure': 'Number of participants with all-cause death', 'timeFrame': '3 month'}, {'measure': 'Number of participants with all-cause death', 'timeFrame': '6 month'}, {'measure': 'Number of participants with all-cause death', 'timeFrame': '12 month'}, {'measure': 'severe blooding complications', 'timeFrame': '1 month'}, {'measure': 'severe blooding complications', 'timeFrame': '3 month'}, {'measure': 'severe blooding complications', 'timeFrame': '6 month'}, {'measure': 'severe blooding complications', 'timeFrame': '12 month'}, {'measure': 'cardio-cerebrovascular complications', 'timeFrame': '1 month'}, {'measure': 'cardio-cerebrovascular complications', 'timeFrame': '3 month'}, {'measure': 'cardio-cerebrovascular complications', 'timeFrame': '6 month'}, {'measure': 'cardio-cerebrovascular complications', 'timeFrame': '12 month'}, {'measure': 'Number of participants with cardiovascular death events', 'timeFrame': '1 month'}, {'measure': 'Number of participants with cardiovascular death events', 'timeFrame': '3 month'}, {'measure': 'Number of participants with cardiovascular death events', 'timeFrame': '6 month'}, {'measure': 'Number of participants with cardiovascular death events', 'timeFrame': '12 month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'To compare the efficacy of different procedures, identify the optimal procedure, ablation sites, ablation endpoints and post-operative anticoagulation strategy, establish the optimal treatment strategy for atrial fibrillation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Atrial fibrillation recorded by ECG or Holter;\n2. Age: 18 \\~ 75 years;\n3. Patients who are willing to enroll in the trial\n\nExclusion Criteria:\n\n1. Patients accompanied hyperthyroidism;\n2. Patients with sever liver or renal dysfunction;\n3. Patients with sever cardiac dysfunction;\n4. Patients had previous radiofrequency catheter ablation in the LA or Maze surgical procedure;\n5. Patients with emboli in atrium;\n6. Pregnant woman'}, 'identificationModule': {'nctId': 'NCT01113294', 'briefTitle': 'Efficacy and Safety Study of Catheter Ablation for Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Wuhan University'}, 'officialTitle': 'Catheter Ablation for Atrial Fibrillation: A Multicenter Clinical Trial', 'orgStudyIdInfo': {'id': 'AFCT001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ablation', 'interventionNames': ['Procedure: catheter ablation']}], 'interventions': [{'name': 'catheter ablation', 'type': 'PROCEDURE', 'description': 'circumferential pulmonary vein isolation complex fractionated atrial electrograms ablation circumferential pulmonary vein isolation combined left atrial roof ablation circumferential pulmonary vein isolation combined left atrial isthmus ablation circumferential pulmonary vein isolation combined left atrial roof and isthmus ablation circumferential pulmonary vein isolation combined complex fractionated atrial electrograms ablation', 'armGroupLabels': ['ablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430060', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Cong-xin Huang, doctor', 'role': 'CONTACT', 'email': 'huangcongxin@yahoo.com.cn', 'phone': '13907131546'}, {'name': 'Cong-xin Huang, doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Renmin Hospital of Wuhan University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Cong-xin Huang, doctor', 'role': 'CONTACT', 'email': 'huangcongxin@yahoo.com.cn', 'phone': '13907131546'}], 'overallOfficials': [{'name': 'Cong-xin Huang, doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Renmin Hospital of Wuhan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wuhan University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Peking Union Medical College', 'class': 'OTHER'}, {'name': 'Shanghai Chest Hospital', 'class': 'OTHER'}, {'name': 'Nanjing Medical University', 'class': 'OTHER'}, {'name': 'West China Hospital', 'class': 'OTHER'}, {'name': "Guangdong Provincial People's Hospital", 'class': 'OTHER'}, {'name': 'Dalian Medical University', 'class': 'OTHER'}, {'name': 'Capital Medical University', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Cong-xin Huang', 'oldOrganization': 'Renmin hospital of Wuhan university'}}}}