Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT06739512
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-18
First Post:
2024-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pulsed Field Ablation in Three Different Substrate Ablation Strategies for 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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-17', 'studyFirstSubmitDate': '2024-11-24', 'studyFirstSubmitQcDate': '2024-12-17', 'lastUpdatePostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', '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 and Quality of Life Enhancement.', 'timeFrame': 'From enrollment to completion of follow-up（at least 12 months）', 'description': 'Improvement in clinical symptoms (EHRA score) and quality of life measurements (Short Form 36 HealthSurvey).'}, {'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': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ablation', 'atrial fibrillation'], 'conditions': ['Atrial Fibrillation (AF)']}, 'descriptionModule': {'briefSummary': 'This multicenter, randomized, controlled trial aims to evaluate the efficacy and safety of pulsed field ablation (PFA) in patients with persistent atrial fibrillation (PeAF). We will compare three distinct substrate ablation strategies: anatomical guided ablation (ANAT group), electrogram guided ablation (EGM group), and extensive electro-anatomical guided ablation (EXT group). The study seeks to identify which ablation strategy yields the highest efficacy and safety profiles to potentially guide future clinical practice in the management of PeAF.'}, '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.\n2. 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': 'NCT06739512', 'briefTitle': 'Pulsed Field Ablation in Three Different Substrate Ablation Strategies for Persistent Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Chest Hospital'}, 'officialTitle': 'Efficacy and Safety of Pulsed Field Ablation in Three Different Substrate Ablation Strategies for Persistent Atrial Fibrillation: a Multicenter Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'EXT-II'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Anatomical Guided Ablation Group', 'description': 'This group will undergo pulmonary vein isolation (PVI) combined with anatomical linear ablation based on predefined anatomical landmarks (a complete posterior wall box isolation to ensure comprehensive atrial substrate modification), including lines such as the mitral isthmus and roofline. The ablation will aim to create bidirectional block without relying on electrogram-based mapping.', 'interventionNames': ['Procedure: Anatomical Guided Ablation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Electrogram Guided Ablation Group', 'description': 'This group will undergo PVI and targeted ablation of atrial fibrillation "drivers" identified through electrogram-guided mapping. The mapping will focus on electrograms with characteristics such as spatial-temporal dispersion, high-frequency potentials, and short local cycle lengths.', 'interventionNames': ['Procedure: Electrogram Guided Ablation']}, {'type': 'EXPERIMENTAL', 'label': 'Extensive Electro-Anatomical Guided Ablation Group', 'description': 'This group will receive PVI and a combination of anatomical linear ablation (a complete posterior wall box isolation to ensure comprehensive atrial substrate modification) and electrogram-guided ablation. It represents an extensive strategy that integrates both anatomical and potential-based mapping for optimized ablation targeting.', 'interventionNames': ['Procedure: Extensive Electro-Anatomical Guided Ablation']}], 'interventions': [{'name': 'Extensive Electro-Anatomical Guided Ablation', 'type': 'PROCEDURE', 'description': 'Ablation using PFA. Combination of anatomical and electrogram-guided ablation techniques.', 'armGroupLabels': ['Extensive Electro-Anatomical Guided Ablation Group']}, {'name': 'Anatomical Guided Ablation', 'type': 'PROCEDURE', 'description': 'Ablation using PFA. Guided by anatomical landmarks without potential mapping', 'armGroupLabels': ['Anatomical Guided Ablation Group']}, {'name': 'Electrogram Guided Ablation', 'type': 'PROCEDURE', 'description': 'Ablation using PFA. Guided by real-time electrogram characteristics from a multi-electrode catheter.', 'armGroupLabels': ['Electrogram Guided Ablation Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Xu Liu, MD', 'role': 'CONTACT', 'email': 'drliux@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'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], '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': "Jinan People's Hospital", 'class': 'UNKNOWN'}, {'name': 'Xuzhou Central Hospital', 'class': 'OTHER'}, {'name': 'The PLA Navy Anqing Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Xu Liu', 'investigatorAffiliation': 'Shanghai Chest Hospital'}}}}