Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT05085912
Status:
UNKNOWN
Last Update Posted:
2021-10-20
First Post:
2021-10-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Driver Ablation of Persistent Atrial Fibrillation With Severe Atrial Fibrosis.
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': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2024-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-18', 'studyFirstSubmitDate': '2021-10-05', 'studyFirstSubmitQcDate': '2021-10-18', 'lastUpdatePostDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative atrial fibrillation (AF)/atrial flutter (AFL)/atrial tachycardia (AT) recurrence rate', 'timeFrame': 'up to 12 months after ablation', 'description': 'AF/AFL/AT recurrence is defined as presence of documented AF/AFL/AT episodes of 30 seconds or longer duration'}, {'measure': 'Intraoperative AF termination rate', 'timeFrame': 'through ablation completion, an average of 3 hours', 'description': 'AF termination is defined as conversion to sinus rhythm or stable AFL/AT.'}], 'secondaryOutcomes': [{'measure': 'Postoperative AF recurrence rate', 'timeFrame': 'up to 12 months after ablation', 'description': 'AF recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration'}, {'measure': 'Postoperative AFL/AT rate', 'timeFrame': 'up to 12 months after ablation', '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 12 months after ablation', 'description': 'death, atrioesophageal fistula, cardiac tamponade/perforation, myocardial infarction, stroke/cerebrovascular accident, thromboembolism, diaphragmatic paralysis, pneumothorax, heart block, pulmonary vein stenosis, pulmonary edema, pericarditis and major vascular access complication or bleeding'}, {'measure': 'Changes in the diameter of the left atrium', 'timeFrame': 'up to 12 months after ablation', 'description': 'Changes in the diameter of the left atrium'}, {'measure': 'Changes in the left ventricular ejection fraction', 'timeFrame': 'up to 12 months after ablation', 'description': 'Changes in the left ventricular ejection fraction'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['persistent atrial fibrillation', 'severe atrial fibrosis', 'driver ablation'], 'conditions': ['Persistent Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'This is an open label, randomized parallel control clinical trial, to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation with severe atrial fibrosis, and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial fibrillation with severe atrial fibrosis.', 'detailedDescription': 'This is an open label, randomized parallel control clinical trial. Patients with persistent atrial fibrillation with severe atrial fibrosis are 1:1:1 randomized into group A (circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation), group B (circumferential pulmonary vein isolation + linear ablation + posterior wall box isolation) and group C (circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion). Postoperative recurrence rate and other indicators are analyzed to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation with severe atrial fibrosis and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial fibrillation with severe atrial fibrosis.'}, '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 with severe atrial fibrosis;\n3. Nonresponse or intolerance to ≥1 antiarrhythmic drug.\n\nExclusion Criteria:\n\n1. With uncontrolled congestive heart failure;\n2. Having significant valvular disease;\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;\n10. Having any contraindication to right or left sided heart catheterization; 11. Previous atrial fibrillation ablation;\n\n12\\. Presence of an implanted cardioverter-defibrillator; 13. Previous history of cardiac surgery; 14. Poor general health; 15. Life expectancy less than 6 months.'}, 'identificationModule': {'nctId': 'NCT05085912', 'briefTitle': 'Driver Ablation of Persistent Atrial Fibrillation With Severe Atrial Fibrosis.', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Chest Hospital'}, 'officialTitle': 'A Randomized Control Study of Driver Ablation of Persistent Atrial Fibrillation With Severe Atrial Fibrosis: a Chinese Registry Study.', 'orgStudyIdInfo': {'id': 'DAAF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation', 'interventionNames': ['Procedure: Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'Circumferential pulmonary vein isolation + linear ablation + posterior wall box isolation', 'interventionNames': ['Procedure: Circumferential pulmonary vein isolation + linear ablation + posterior wall box isolation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group C', 'description': 'Circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion', 'interventionNames': ['Procedure: Circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion']}], 'interventions': [{'name': 'Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation', 'type': 'PROCEDURE', 'description': 'Patients receive circumferential pulmonary vein isolation and linear ablation (ablation of a roof line and a mitral isthmus line) combined with bi-atrial mapping and driver ablation.', 'armGroupLabels': ['Group A']}, {'name': 'Circumferential pulmonary vein isolation + linear ablation + posterior wall box isolation', 'type': 'PROCEDURE', 'description': 'Patients receive circumferential pulmonary vein isolation and linear ablation (ablation of a roof line and a mitral isthmus line) combined with posterior wall box isolation.', 'armGroupLabels': ['Group B']}, {'name': 'Circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion', 'type': 'PROCEDURE', 'description': 'Patients receive circumferential pulmonary vein isolation and linear ablation (ablation of a roof line and a mitral isthmus line) combined with vein of Marshall ethanol infusion.', 'armGroupLabels': ['Group C']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mu Qin, M.D.', 'role': 'CONTACT', 'email': 'qinmuae@163.com', 'phone': '+8613052320103'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Chest Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, deputy director of cardiology department of Shanghai Chest Hospita', 'investigatorFullName': 'Xu Liu', 'investigatorAffiliation': 'Shanghai Chest Hospital'}}}}