Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-26 @ 6:24 PM
Study NCT ID:
NCT04489004
Status:
COMPLETED
Last Update Posted:
2023-02-06
First Post:
2020-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Chinese Registration Study of Driver Ablation of Persistent 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1298}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-02', 'studyFirstSubmitDate': '2020-07-24', 'studyFirstSubmitQcDate': '2020-07-24', 'lastUpdatePostDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative atrial fibrillation (AF) recurrence rate', 'timeFrame': 'up to 24 months after enrollment', 'description': 'AF recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration.'}, {'measure': 'Procedural AF termination rate', 'timeFrame': 'Before the end of procedure.', 'description': 'AF termination is defined as conversion to sinus rhythm or a stable atrial flutter (AFL)/atrial tachycardia (AT).'}], 'secondaryOutcomes': [{'measure': 'Postoperative atrial flutter (AFL) or atrial tachycardia (AT) rate', 'timeFrame': 'up to 24 months after enrollment', 'description': 'Occurrence of AFL/AT is defined as presence of documented AFL/AT episodes of 30 seconds or longer duration.'}, {'measure': 'Incidence of complications', 'timeFrame': 'up to 2 weeks after enrollment', 'description': 'Complications include: death, atrioesophageal fistula, cardiac tamponade/perforation, myocardial infarction, stroke/cerebrovascular accident, thromboembolism, transient ischemic attack (TIA), diaphragmatic paralysis, pneumothorax, heart block, pulmonary vein stenosis, pulmonary edema, pericarditis, and major vascular access complication or bleeding.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Persistent Atrial Fibrillation', 'Driver ablation', 'Stepwise ablation'], 'conditions': ['Atrial Fibrillation, Persistent']}, 'descriptionModule': {'briefSummary': 'This is an open label, multi-center, randomized parallel control clinical trial, to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation, and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial fibrillation.', 'detailedDescription': 'This is an open label, multi-center, randomized parallel control clinical trial. Patients with persistent atrial fibrillation are 1:1 randomized into the experimental group (driver ablation+ circumferential pulmonary vein isolation) or the control group (stepwise ablation). Postoperative atrial fibrillation recurrence rate and other indicators are analyzed to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial fibrillation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 18 to 80 years old;\n2. Persistent AF;\n3. nonresponse or intolerance to ≥1 antiarrhythmic drug. -\n\nExclusion Criteria:\n\n1. With uncontrolled congestive heart failure;\n2. Having significant valvular disease and/or prosthetic heart valve(s);\n3. With myocardial infarction or stroke within 6 months of screening;\n4. With Significant congenital heart disease;\n5. Ejection fraction was \\<40% measured by echocardiography;\n6. Allergic to contrast media;\n7. Contraindication to anticoagulation medications;\n8. Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD);\n9. Left atrial (LA) thrombus measured by pre-procedure transesophageal echocardiography;\n10. Having any contraindication to right or left sided heart catheterization;\n11. Previous atrial fibrillation ablation;\n12. Presence of an implanted cardioverter-defibrillator;\n13. Any cardiac surgery within the past 2 months;\n14. Poor general health;\n15. Life expectancy less than 6 months.'}, 'identificationModule': {'nctId': 'NCT04489004', 'briefTitle': 'The Chinese Registration Study of Driver Ablation of Persistent Atrial Fibrillation.', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Chest Hospital'}, 'officialTitle': 'Credit-AF: A Randomized Control Study of Driver Ablation Combined With Circumferential Pulmonary Vein Isolation Versus Stepwise Ablation as a Treatment in Patients With Persistent Atrial Fibrillation.', 'orgStudyIdInfo': {'id': 'Credit-AF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Driver ablation+CPVI', 'description': 'Driver ablation plus CPVI (circumferential pulmonary vein isolation)', 'interventionNames': ['Procedure: Driver ablation+CPVI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stepwise ablation', 'description': 'Stepwise ablation', 'interventionNames': ['Procedure: Stepwise ablation']}], 'interventions': [{'name': 'Driver ablation+CPVI', 'type': 'PROCEDURE', 'description': 'Patients receive driver ablation and CPVI (circumferential pulmonary vein isolation).', 'armGroupLabels': ['Driver ablation+CPVI']}, {'name': 'Stepwise ablation', 'type': 'PROCEDURE', 'description': 'Patients receive stepwise ablation.', 'armGroupLabels': ['Stepwise ablation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'country': 'China', 'facility': 'Shanghai Chest Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Chest Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, deputy director of cardiology department of Shanghai Chest Hospital', 'investigatorFullName': 'Xu Liu', 'investigatorAffiliation': 'Shanghai Chest Hospital'}}}}