Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2025-12-26 @ 3:44 AM
Study NCT ID:
NCT06499818
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CPVI Alone Versus CPVI Plus Low-Voltage Areas Ablation During SR Versus CPVI Plus Low-Voltage Areas Ablation During AF for the Treatment of CAF
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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-03-23', 'size': 345639, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-06-25T04:56', 'hasProtocol': True}, {'date': '2024-03-23', 'size': 212081, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-06-25T04:56', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2026-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-11', 'studyFirstSubmitDate': '2024-07-07', 'studyFirstSubmitQcDate': '2024-07-11', 'lastUpdatePostDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of no atrial arrhythmias greater than 30 seconds', 'timeFrame': 'at least 18 months follow up', 'description': 'The incidence of no atrial arrhythmias greater than 30 seconds'}], 'secondaryOutcomes': [{'measure': 'No use of antiarrhythmic drugs and no occurrence of atrial fibrillation exceeding 30 seconds', 'timeFrame': 'at least 18 months follow up', 'description': 'No use of antiarrhythmic drugs and no occurrence of atrial fibrillation exceeding 30 seconds'}, {'measure': 'No use of antiarrhythmic drugs and no occurrence of atrial tachycardia/flutter exceeding 30 seconds', 'timeFrame': 'at least 18 months follow up', 'description': 'No use of antiarrhythmic drugs and no occurrence of atrial tachycardia/flutter exceeding 30 seconds'}, {'measure': 'Atrial fibrillation load', 'timeFrame': 'at least 18 months follow up', 'description': 'Atrial fibrillation load'}, {'measure': 'Procedure time', 'timeFrame': 'Surgical procedure', 'description': 'time that the patient spend in the procedure room'}, {'measure': 'Ablation time', 'timeFrame': '1 week after patient enrollment', 'description': 'the total Ablation time, during CPVI and after CPVI'}, {'measure': 'Incidence of peri-procedural complications', 'timeFrame': 'at least 18 months follow up', 'description': 'stroke, PV stenosis, cardiac perforation, esophageal injury and death'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'The primary objective of this investigation is to compare the efficacy of Three different AF ablation strategies in patients with Persistent atrial fibrillation: CPVI plus Low-Voltage Areas ablation during sinus rhythm Versus. CPVI Plus Low-Voltage Areas Ablation During AF and CPVI alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients age is 18-80 years;\n2. Patients with non-paroxysmal AF; non-paroxysmal AF will be defined as a sustained episode lasting \\> 7 days;\n3. Patients can sign the written informed consent for the study;\n4. Patients can endure the required follow-up.\n\nExclusion Criteria:\n\n1. Patients who had previously undergone atrial fibrillation, atrial tachycardia, or atypical atrial flutter ablation\n2. Preoperative combined atrial tachycardia (≥30S) and atypical atrial flutter\n3. Left atrial diameter \\>55mm\n4. Left ventricular ejection fraction \\<35%\n5. Left atrial thrombus\n6. Postoperative cardiac surgery\n7. After valve replacement\n8. After permanent pacemaker implantation\n9. hypertrophic cardiomyopathy\n10. Patients with moderate-to-severe aortic valve disease, moderate-to-severe mitral stenosis, and severe other valvular disease\n11. Hemorrhagic stroke within 6 months\n12. Transient ischemic attack or ischemic stroke within 1 month\n13. Mental disorder or history of mental illness and inability to cooperate voluntarily\n14. Breastfeeding, pregnancy and women planning or likely to become pregnant\n15. Life expectancy \\<12 months\n16. Participating in other interventional clinical trials\n17. The researchers judged that it was not suitable for inclusion in this study'}, 'identificationModule': {'nctId': 'NCT06499818', 'briefTitle': 'CPVI Alone Versus CPVI Plus Low-Voltage Areas Ablation During SR Versus CPVI Plus Low-Voltage Areas Ablation During AF for the Treatment of CAF', 'organization': {'class': 'OTHER', 'fullName': 'Yantai Yuhuangding Hospital'}, 'officialTitle': 'Circumferential Pulmonary Vein Isolation Alone Versus CPVI Plus Low-Voltage Areas Ablation During SR Versus CPVI Plus Low-Voltage Areas Ablation During AF for the Treatment of CAF', 'orgStudyIdInfo': {'id': '2024-226'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'STABLE-SR', 'interventionNames': ['Procedure: STABLE-SR']}, {'type': 'EXPERIMENTAL', 'label': 'STABLE-AF', 'interventionNames': ['Procedure: STABLE-AF']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CPVI alone', 'interventionNames': ['Procedure: CPVI']}], 'interventions': [{'name': 'STABLE-SR', 'type': 'PROCEDURE', 'description': 'homogenization of the low voltage zones and elimination of the complex electrograms from the transitional zones during sinus rhythm', 'armGroupLabels': ['STABLE-SR']}, {'name': 'STABLE-AF', 'type': 'PROCEDURE', 'description': 'homogenization of the low voltage zones and elimination of the complex electrograms from the transitional zones during Atrial Fibrillation', 'armGroupLabels': ['STABLE-AF']}, {'name': 'CPVI', 'type': 'PROCEDURE', 'description': 'ablate around the pulmonary vein orifice', 'armGroupLabels': ['CPVI alone']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hongxia Chu, doctorate', 'role': 'CONTACT', 'email': 'chuhx1972@163.com', 'phone': '15965165932'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yantai Yuhuangding Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}