Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-25 @ 9:45 PM
Study NCT ID:
NCT04702451
Status:
COMPLETED
Last Update Posted:
2025-09-12
First Post:
2021-01-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Tailored vs. Anatomical Ablation Strategy for Persistent Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
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'Tailored', 'description': 'Tailored ablation strategy\n\nDispersion ablation + PVI: Ablation of spatio-temporal dispersion electrograms in combination with pulmonary vein antrum isolation\n\nVX1: VX1-based dispersion mapping', 'otherNumAtRisk': 187, 'deathsNumAtRisk': 187, 'otherNumAffected': 12, 'seriousNumAtRisk': 187, 'deathsNumAffected': 2, 'seriousNumAffected': 21}, {'id': 'EG001', 'title': 'Anatomical', 'description': 'Anatomical ablation strategy\n\nPVI: Pulmonary vein antrum isolation', 'otherNumAtRisk': 183, 'deathsNumAtRisk': 183, 'otherNumAffected': 10, 'seriousNumAtRisk': 183, 'deathsNumAffected': 0, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Cardiac tamponade or 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1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Transient phrenic nerve palsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pericarditis or pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vascular access complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Post-ablation fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abnormal ECG requiring hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Transient ischemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Free From Documented AF After One Ablation Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tailored', 'description': 'Tailored ablation strategy\n\nDispersion ablation + PVI: Ablation of spatio-temporal dispersion electrograms in combination with pulmonary vein antrum isolation\n\nVX1: VX1-based dispersion mapping'}, {'id': 'OG001', 'title': 'Anatomical', 'description': 'Anatomical ablation strategy\n\nPVI: Pulmonary vein antrum isolation'}], 'classes': [{'categories': [{'measurements': [{'value': '158', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Freedom from documented AF episodes \\> 30 seconds, with or without anti-arrhythmic drugs (AADs), 12 months after a single index ablation procedure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT: all randomized participants except for those who were deemed ineligible after randomization and before the ablation procedure, those who did not have any ablation procedure, and those lost to follow-up during the 3-month blanking period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Free From Documented AF/AT After One or Two Ablation Procedures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tailored', 'description': 'Tailored ablation strategy\n\nDispersion ablation + PVI: Ablation of spatio-temporal dispersion electrograms in combination with pulmonary vein antrum isolation\n\nVX1: VX1-based dispersion mapping'}, {'id': 'OG001', 'title': 'Anatomical', 'description': 'Anatomical ablation strategy\n\nPVI: Pulmonary vein antrum isolation'}], 'classes': [{'categories': [{'measurements': [{'value': '136', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Freedom from documented AF/AT episodes \\> 30 seconds, after one or two procedures, with or without AADs, at 12 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT: all randomized participants except for those who were deemed ineligible after randomization and before the ablation procedure, those who did not have any ablation procedure, and those lost to follow-up during the 3-month blanking period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Free From Documented AF/AT After One Ablation Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tailored', 'description': 'Tailored ablation strategy\n\nDispersion ablation + PVI: Ablation of spatio-temporal dispersion electrograms in combination with pulmonary vein antrum isolation\n\nVX1: VX1-based dispersion mapping'}, {'id': 'OG001', 'title': 'Anatomical', 'description': 'Anatomical ablation strategy\n\nPVI: Pulmonary vein antrum isolation'}], 'classes': [{'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Freedom from documented AF/AT episodes \\> 30 seconds, with or without AADs, 12 months after a single ablation procedure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT: all randomized participants except for those who were deemed ineligible after randomization and before the ablation procedure, those who did not have any ablation procedure, and those lost to follow-up during the 3-month blanking period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Complications (Safety Composite Endpoint)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tailored', 'description': 'Tailored ablation strategy\n\nDispersion ablation + PVI: Ablation of spatio-temporal dispersion electrograms in combination with pulmonary vein antrum isolation\n\nVX1: VX1-based dispersion mapping'}, {'id': 'OG001', 'title': 'Anatomical', 'description': 'Anatomical ablation strategy\n\nPVI: Pulmonary vein antrum isolation'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Complications at 12 months: death, cerebrovascular events, or serious treatment-related adverse event', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all randomized participants who underwent their first ablation procedure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tailored', 'description': 'Tailored ablation strategy\n\nDispersion ablation + PVI: Ablation of VX1-based spatio-temporal dispersion electrograms in combination with pulmonary vein antrum isolation'}, {'id': 'FG001', 'title': 'Anatomical', 'description': 'Anatomical ablation strategy\n\nPVI: Pulmonary vein antrum isolation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '188'}, {'groupId': 'FG001', 'numSubjects': '186'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '174'}, {'groupId': 'FG001', 'numSubjects': '174'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '12'}]}]}], 'preAssignmentDetails': 'Among the 377 patients enrolled, 3 patients did not receive any ablation, because their ablation was cancelled or postponed. They were therefore not randomized and exited the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '370', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tailored', 'description': 'Tailored ablation strategy\n\nDispersion ablation + PVI: Ablation of spatio-temporal dispersion electrograms in combination with pulmonary vein antrum isolation\n\nVX1: VX1-based dispersion mapping'}, {'id': 'BG001', 'title': 'Anatomical', 'description': 'Anatomical ablation strategy\n\nPVI: Pulmonary vein antrum isolation'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '370', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '66.4', 'spread': '8.5', 'groupId': 'BG000'}, {'value': '64.9', 'spread': '8.5', 'groupId': 'BG001'}, {'value': '65.7', 'spread': '8.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '370', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '145', 'groupId': 'BG000'}, {'value': '148', 'groupId': 'BG001'}, {'value': '293', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Netherlands', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '370', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '370', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '370', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}, {'title': 'France', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '370', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '128', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '370', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The baseline safety population included all randomized participants who underwent their first ablation procedure.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-07-06', 'size': 2188148, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-09-11T09:58', 'hasProtocol': True}, {'date': '2024-02-19', 'size': 487466, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-09-11T09:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Controlled Trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 377}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-11', 'studyFirstSubmitDate': '2021-01-07', 'resultsFirstSubmitDate': '2025-03-25', 'studyFirstSubmitQcDate': '2021-01-07', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-11', 'studyFirstPostDateStruct': {'date': '2021-01-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Free From Documented AF After One Ablation Procedure', 'timeFrame': '12 months', 'description': 'Freedom from documented AF episodes \\> 30 seconds, with or without anti-arrhythmic drugs (AADs), 12 months after a single index ablation procedure'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Free From Documented AF/AT After One or Two Ablation Procedures', 'timeFrame': '12 months', 'description': 'Freedom from documented AF/AT episodes \\> 30 seconds, after one or two procedures, with or without AADs, at 12 months'}, {'measure': 'Number of Participants Free From Documented AF/AT After One Ablation Procedure', 'timeFrame': '12 months', 'description': 'Freedom from documented AF/AT episodes \\> 30 seconds, with or without AADs, 12 months after a single ablation procedure'}, {'measure': 'Number of Participants With Complications (Safety Composite Endpoint)', 'timeFrame': '12 months', 'description': 'Complications at 12 months: death, cerebrovascular events, or serious treatment-related adverse event'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Persistent Atrial Fibrillation', 'Catheter Ablation', 'Electrogram dispersion'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '28104073', 'type': 'BACKGROUND', 'citation': 'Seitz J, Bars C, Theodore G, Beurtheret S, Lellouche N, Bremondy M, Ferracci A, Faure J, Penaranda G, Yamazaki M, Avula UM, Curel L, Siame S, Berenfeld O, Pisapia A, Kalifa J. AF Ablation Guided by Spatiotemporal Electrogram Dispersion Without Pulmonary Vein Isolation: A Wholly Patient-Tailored Approach. J Am Coll Cardiol. 2017 Jan 24;69(3):303-321. doi: 10.1016/j.jacc.2016.10.065.'}, {'pmid': '35989543', 'type': 'BACKGROUND', 'citation': 'Seitz J, Durdez TM, Albenque JP, Pisapia A, Gitenay E, Durand C, Monteau J, Moubarak G, Theodore G, Lepillier A, Zhao A, Bremondy M, Maluski A, Cauchemez B, Combes S, Guyomar Y, Heuls S, Thomas O, Penaranda G, Siame S, Appetiti A, Milpied P, Bars C, Kalifa J. Artificial intelligence software standardizes electrogram-based ablation outcome for persistent atrial fibrillation. J Cardiovasc Electrophysiol. 2022 Nov;33(11):2250-2260. doi: 10.1111/jce.15657. Epub 2022 Sep 18.'}, {'pmid': '39953289', 'type': 'RESULT', 'citation': 'Deisenhofer I, Albenque JP, Busch S, Gitenay E, Mountantonakis SE, Roux A, Horvilleur J, Bakouboula B, Oza S, Abbey S, Theodore G, Lepillier A, Guyomar Y, Bessiere F, Jan Smit J, Mohr Durdez T, Milpied P, Appetiti A, Guerrero D, De Potter T, De Chillou C, Goldbarg S, Verma A, Hummel JD; TAILORED-AF Investigators. Artificial intelligence for individualized treatment of persistent atrial fibrillation: a randomized controlled trial. Nat Med. 2025 Apr;31(4):1286-1293. doi: 10.1038/s41591-025-03517-w. Epub 2025 Feb 14.'}, {'pmid': '41311304', 'type': 'DERIVED', 'citation': 'Deisenhofer I, Seitz J, Nguyen-Tu MS, Lotteau S, Bars C, Albenque JP, Busch S, Gitenay E, Mountantonakis S, Roux A, Horvilleur J, Bakouboula B, Oza S, Abbey S, Theodore G, Lepillier A, Guyomar Y, Bessiere F, Smit JJ, Rajendra A, Cooper DH, Rashid H, De Potter T, De Chillou C, Goldbarg S, Verma A, Morales G, Milpied P, Hummel JD, Kalifa J. Women with persistent atrial fibrillation need more than pulmonary vein isolation: personalised extra-pulmonary vein ablation strategy vs. pulmonary vein isolation alone in the TAILORED-AF trial. Europace. 2025 Oct 31;27(11):euaf281. doi: 10.1093/europace/euaf281.'}]}, 'descriptionModule': {'briefSummary': 'Atrial Fibrillation (AF) ablation is typically performed in predefined anatomic regions of the left atrium without attempting to identify patient-specific areas of interest. This procedure is referred to as Pulmonary Vein Isolation (PVI).\n\nThe hypothesis in this Study is that a tailored ablation strategy targeting areas of spatio-temporal dispersion in combination with PVI is superior to an anatomical ablation strategy targeting PVI alone for the treatment of persistent AF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients 18 years of age or older candidates for a first AF ablation\n* Symptomatic AF, refractory to at least one antiarrhythmic medication\n* Persistent or long-standing persistent AF with documentation of (ECG, Holter, physician's letter): AF duration of ≥ 3 months and ≤ 5 years (≥ 3 months and \\< 1 year in the United States) or 1 effective cardioversion followed by AF recurrence lasting ≥ 3 months\n* Continuous anticoagulation with warfarin (INR 2-3) or NOAC for \\> 4 weeks prior to ablation\n* Patients must be able and willing to provide written informed consent to participate in the clinical trial\n* At least 60% of patients (224 patients) in persistent AF ≥ 6 months including at least 15% (56 patients) of long-standing persistent AF ≥ 12 months\n\nExclusion Criteria:\n\n* Paroxysmal and short-standing AF \\< 3 months\n* Long-standing persistent AF \\> 5 years (≥ 1 year in the United States)\n* ≥ 2 previous ineffective cardioversion sessions in case of undetermined AF duration\n* Severe obesity (BMI \\> 40)\n* Very dilated Left Atrium (LA)(e.g. LA diameter \\> 60 mm and/or LA surface \\> 40 cm2 determined by 2D echocardiography)\n* Patients with AF secondary to an obvious reversible cause\n* Inadequate anticoagulation as defined in the inclusion criteria\n* LA thrombus on Transesophageal Echocardiography (TEE) or CT Scan prior to procedure\n* Contraindications to anticoagulation (heparin, warfarin or NOAC)\n* Patients who are or may potentially be pregnant\n* Previous surgical or catheter ablation for AF\n* Any cardiac surgery within the past 2 months (60 days) (includes PCI)\n* Myocardial infarction within the past 2 months (60 days)\n* Previous atrioventricular valve surgery\n* History of blood clotting or bleeding abnormalities\n* Documented arterial thromboembolic event (including TIA) within the past 12 months (365 days)\n* Rheumatic Heart Disease\n* Chronic severe Heart Failure (NYHA functional class IV and/or LVEF \\< 25%)\n* Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days)\n* Unstable angina within the past month\n* Acute illness or active systemic infection or sepsis\n* AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause\n* Diagnosed atrial myxoma\n* Significant severe pulmonary disease, (e.g. patients with restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease in GOLD stage IV) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms (e.g. unstable or untreated sleep apnea)\n* Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment\n* Enrollment in an investigational study evaluating another device, biologic, or drug\n* Presence of intramural thrombus, tumor or other abnormality or condition that precludes vascular access, or manipulation of the catheter\n* Life expectancy or other disease processes likely to limit survival to less than 12 months\n* Acute Covid-19 infection (fever and/or biological inflammatory syndrome, and positive test documented)"}, 'identificationModule': {'nctId': 'NCT04702451', 'acronym': 'Tailored-AF', 'briefTitle': 'Tailored vs. Anatomical Ablation Strategy for Persistent Atrial Fibrillation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Volta Medical'}, 'officialTitle': 'Tailored vs. Anatomical Ablation Strategy for Persistent Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'CLIPL-01-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tailored', 'description': 'Tailored ablation strategy', 'interventionNames': ['Procedure: Dispersion ablation + PVI', 'Device: VX1']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Anatomical', 'description': 'Anatomical ablation strategy', 'interventionNames': ['Procedure: PVI']}], 'interventions': [{'name': 'Dispersion ablation + PVI', 'type': 'PROCEDURE', 'description': 'Ablation of spatio-temporal dispersion electrograms in combination with pulmonary vein antrum isolation', 'armGroupLabels': ['Tailored']}, {'name': 'VX1', 'type': 'DEVICE', 'description': 'VX1-based dispersion mapping', 'armGroupLabels': ['Tailored']}, {'name': 'PVI', 'type': 'PROCEDURE', 'description': 'Pulmonary vein antrum isolation', 'armGroupLabels': ['Anatomical']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35243', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Grandview 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