Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-01-06 @ 11:02 AM
Study NCT ID:
NCT06745167
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-20
First Post:
2024-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Efficacy and Safety of Extensive Electro-Anatomical Guided Pulsed Field Ablation Versus Radiofrequency Ablation in 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078703', 'term': 'Radiofrequency Ablation'}], 'ancestors': [{'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-19', 'studyFirstSubmitDate': '2024-11-25', 'studyFirstSubmitQcDate': '2024-12-19', 'lastUpdatePostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Freedom from Atrial Arrhythmia Recurrence at 12 Months', 'timeFrame': '12 months after ablation procedure', 'description': 'Proportion of participants free from atrial fibrillation/atrial flutter/atrial tachycardia recurrence at 12 months post-ablation.'}], 'secondaryOutcomes': [{'measure': 'Procedural Safety', 'timeFrame': 'From enrollment to completion of follow-up（at least 12 months）', 'description': 'Incidence of procedural complications such as esophageal injury and pulmonary vein stenosis.'}, {'measure': 'Symptom Relief (EHRA scores)', 'timeFrame': 'From enrollment to completion of follow-up（at least 12 months）', 'description': 'Improvement in clinical symptoms (EHRA scores)'}, {'measure': 'Quality of Life (Short Form 36 Health Survey).', 'timeFrame': 'From enrollment to completion of follow-up（at least 12 months）', 'description': 'quality of life measurements (Short Form 36 Health Survey).'}, {'measure': 'Atrial Fibrillation Burden Reduction', 'timeFrame': 'From enrollment to completion of follow-up（at least 12 months）', 'description': 'Reduction in atrial fibrillation burden assessed through follow-up evaluations.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['atrial fibrillation', 'pulsed field ablation', 'radiofrequency ablation'], 'conditions': ['Atrial Fibrillation (AF)']}, 'descriptionModule': {'briefSummary': 'This multicenter, randomized controlled trial aims to compare the efficacy and safety of extensive electro-anatomical guided pulsed field ablation (EXT-PFA) with traditional radiofrequency ablation (RF) in treating persistent atrial fibrillation (PeAF). The trial seeks to determine if EXT-PFA, which integrates anatomical and electrogram-guided strategies, can provide superior outcomes in terms of safety and effectiveness compared to the standard RF ablation approach.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1.Adults aged 18-80 years diagnosed with persistent atrial fibrillation. 2.Ineffectiveness or intolerance to at least one Class I or III anti-arrhythmic drug.\n\nExclusion Criteria:\n\n1. Major valvular diseases needing surgical intervention.\n2. Presence of a left atrial thrombus on recent imaging.\n3. Recent myocardial infarction or severe heart failure (LVEF ≤ 30%).\n4. Current Severe Infection.'}, 'identificationModule': {'nctId': 'NCT06745167', 'briefTitle': 'Comparative Efficacy and Safety of Extensive Electro-Anatomical Guided Pulsed Field Ablation Versus Radiofrequency Ablation in Persistent Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Chest Hospital'}, 'officialTitle': 'Comparative Efficacy and Safety of Electro-Anatomical Guided Pulsed Field Ablation Versus Radiofrequency Ablation in the Treatment of Persistent Atrial Fibrillation: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'EXT-III'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pulsed field ablation', 'description': 'Utilizing pulsed field ablation (PFA), combining pulmonary vein isolation (PVI) with extensive ablation based on anatomical landmarks (including posterior wall box isolation) and electrogram-guided ablation, aiming to target all potential arrhythmic substrates.', 'interventionNames': ['Procedure: Pulsed field ablation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Radiofrequency Ablation', 'description': 'Using conventional radiofrequency ablation technology, combines pulmonary vein isolation (PVI) with extensive ablation based on anatomical landmarks (including posterior wall box isolation) and electrogram-guided ablation, aiming to target all potential arrhythmic substrates.', 'interventionNames': ['Procedure: Radiofrequency ablation alone']}], 'interventions': [{'name': 'Pulsed field ablation', 'type': 'PROCEDURE', 'description': 'Utilizing pulsed field ablation (PFA), combining pulmonary vein isolation (PVI) with extensive ablation based on anatomical landmarks (including posterior wall box isolation) and electrogram-guided ablation.', 'armGroupLabels': ['Pulsed field ablation']}, {'name': 'Radiofrequency ablation alone', 'type': 'PROCEDURE', 'description': 'Using conventional radiofrequency ablation technology, combines pulmonary vein isolation (PVI) with extensive ablation based on anatomical landmarks (including posterior wall box isolation) and electrogram-guided ablation', 'armGroupLabels': ['Radiofrequency Ablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Xu Liu, MD', 'role': 'CONTACT', 'email': 'drliuxu@126.com', 'phone': '+86 021-22200000'}], 'facility': 'No. 241, West Huaihai Road', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Xu Liu, MD', 'role': 'CONTACT', 'email': 'drliuxu@126.com', 'phone': '+86 021-22200000'}], 'overallOfficials': [{'name': 'Xu Liu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Chest Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Chest Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Albert Einstein College of Medicine and Montefiore Medical Center', 'class': 'UNKNOWN'}, {'name': 'Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'UNKNOWN'}, {'name': 'Shandong University of Traditional Chinese Medicine', 'class': 'OTHER'}, {'name': "Yuhuan Second People's Hospital", 'class': 'UNKNOWN'}, {'name': 'Changshu Hospital of Traditional Chinese Medicine', 'class': 'OTHER'}, {'name': 'The PLA Navy Anqing Hospital', 'class': 'UNKNOWN'}, {'name': "Jinan People's Hospital", 'class': 'UNKNOWN'}, {'name': 'Xuzhou Central Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Xu Liu', 'investigatorAffiliation': 'Shanghai Chest Hospital'}}}}