Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2026-01-01 @ 11:27 PM
Study NCT ID:
NCT06825104
Status:
RECRUITING
Last Update Posted:
2025-03-13
First Post:
2025-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-Term Evaluation of TAILORED Vs Anatomical Ablation Strategy 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 278}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2025-01-31', 'studyFirstSubmitQcDate': '2025-02-07', 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Long-term freedom from documented atrial fibrillation (AF) after one ablation procedure', 'timeFrame': '60 months', 'description': 'Long-term freedom from documented AF episodes \\> 30 seconds, with or without antiarrhythmic drugs (AADs), after a single index ablation procedure.'}], 'secondaryOutcomes': [{'measure': 'Long-term freedom from documented AF/AT after one or two ablation procedures', 'timeFrame': '60 months', 'description': 'Long-term freedom from documented AF and Atrial Tachycardia (AT) episodes \\> 30 seconds, after one or two procedures, with or without AADs'}, {'measure': 'Long-term freedom from documented AF/AT after one ablation procedure', 'timeFrame': '60 months', 'description': 'Long-term freedom from documented AF/AT episodes \\> 30 seconds, after one procedure, with or without AADs'}, {'measure': 'Heath Economics - Average Number of Ablation Procedures per patient', 'timeFrame': '60 months', 'description': 'To determine how the number of repeat ablation procedures in addition to the index procedure impacts health care costs.'}, {'measure': 'Heath Economics - Average Number of Hospitalizations per patient', 'timeFrame': '60 months', 'description': 'To determine how the number of hospitalizations post-ablation index procedure impacts health care costs.'}, {'measure': 'Heath Economics - Average Number of Cardioversions per patient', 'timeFrame': '60 months', 'description': 'To determine how the number of cardioversions post-ablation index procedure affects health care costs.'}, {'measure': 'Heath Economics - Quality of Life Progression (AFEQT Score)', 'timeFrame': '60 months', 'description': 'To determine how the quality of life progression after the ablation index procedure (measured with the Atrial Fibrillation Effect on Quality of Life Questionnaire AFEQT) impacts health care costs.\n\nAFEQT score ranges from 0 to 100, with higher scores indicating better quality of life.'}, {'measure': 'Heath Economics - Quality of Life Progression (SF-36 Score)', 'timeFrame': '60 months', 'description': 'To determine how the Quality of life progression after the ablation index procedure (measured with the 36-Item Short Form Health Survey SF-36) impacts health care costs.\n\nThe SF-36 consists of eight domains measuring physical and mental health, with scores ranging from 0 to 100 (higher scores indicate better quality of life).'}, {'measure': 'Heath Economics - Proportion of Patients Under AAD', 'timeFrame': '60 months', 'description': 'To determine how the proportion of patients under antiarrhythmic drugs (AAD) impacts health care costs.'}, {'measure': 'Incidence of complications (safety composite endpoint)', 'timeFrame': '60 months', 'description': 'Incidence of complications: death, cerebrovascular events, or serious treatment-related adverse event at long-term.\n\nNOTE: In addition, each component of the composite endpoint will be individually assessed.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Artificial Intelligence', 'VX1', 'Volta AF-Xplorer', 'Medical Device', 'Cardiac Dispersion', 'Volta Medical', 'Software'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '39953289', 'type': 'BACKGROUND', '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': '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.'}]}, 'descriptionModule': {'briefSummary': 'The TAILORED-LT study is conducted as an extension follow-up until 5 years of the initial TAILORED-AF study (NCT04702451), in order to demonstrate the long-term superiority in terms of freedom of atrial fibrillation (AF) of a tailored ablation strategy targeting areas of spatio-temporal dispersed electrograms in combination with pulmonary veins isolation (PVI) over an anatomical ablation strategy targeting PVI alone for the initial ablation procedure of persistent AF.', 'detailedDescription': "The TAILORED-AF study demonstrated at one year's follow-up that a tailored ablation strategy guided by Volta Medical AI-software targeting areas of spatio-temporal dispersed electrograms in combination with pulmonary vein isolation (PVI) ablation is more effective to an anatomical ablation strategy targeting PVI alone (current standard of care) for the treatment of persistent atrial fibrillation (AF).\n\nVX1 legacy device renamed Volta AF-Xplorer was used in the TAILORED-AF study in the treatment arm.\n\nNo additional treatments are specifically required in the scope of this ancillary TAILORED-LT study which aims to follow the patients previously treated in the initial TAILORED-AF study over the long-term. However, in the event of repeat procedures during the TAILORED-LT study, the choice of the ablation technique will be left to the investigator's discretion, regardless of the patient's randomization arm in the TAILORED-AF study.\n\nThe annual follow-up will be performed as in routine clinical practice post AF ablation procedures: visits at 24 months, 36 months, 48 months and 60 months post TAILORED-AF Study index procedure. It is possible that some of these annual visits cannot be completed prospectively due to time already having elapsed between the end of the subject participation in the TAILORED-AF study and the date of enrollment in the extension TAILORED-LT study. In this case, available data (among those expected by the study protocol) will be collected retrospectively.\n\nThe additional procedures related to this clinical investigation are limited to annual 24-hour Holters and to the administration of Quality Of Life questionnaires (SF-36 and AFEQT) to the patients during follow-up visits."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients previously enrolled in TAILORED-AF study, treated for their persistent AF by an index ablation procedure and not withdrawn during the 12-month follow-up period post-index procedure.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient who participated in the Tailored AF study\n* Patient not withdrawn during the 12-month follow-up period post-index procedure in the Tailored AF study\n* Patient able and willing to provide written informed consent to participate in this extension Tailored-LT study\n\nExclusion Criteria:\n\n* Person deprived of liberty or under guardianship\n* Person unable to undergo a medical monitoring for geographical, social or psychological reasons'}, 'identificationModule': {'nctId': 'NCT06825104', 'acronym': 'TAILORED-LT', 'briefTitle': 'Long-Term Evaluation of TAILORED Vs Anatomical Ablation Strategy for Persistent Atrial Fibrillation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Volta Medical'}, 'officialTitle': 'Long-Term Evaluation of TAILORED Vs Anatomical Ablation Strategy for Persistent Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'CLIPL-01-006'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Experimental: Tailored', 'description': 'Patients from the "Tailored" group in the initial study TAILORED-AF. Patients in this group underwent "Tailored" AF ablation, i.e. the analysis and targeting of pathological areas using Volta Medical\'s artificial intelligence software (Volta AF-Xplorer, formerly VX1), in addition to electrical isolation of the pulmonary veins (PVI).', 'interventionNames': ['Device: Volta AF-Xplorer', 'Procedure: Dispersion ablation + PVI']}, {'label': 'Active Comparator: Anatomical', 'description': 'Patients from the "Anatomical" group in the initial study TAILORED-AF. Patients in this group underwent PVI only.', 'interventionNames': ['Procedure: PVI']}], 'interventions': [{'name': 'Volta AF-Xplorer', 'type': 'DEVICE', 'description': 'Dispersion ablation strategy guided by Volta Medical AI-software targeting areas of spatiotemporal dispersed electrograms', 'armGroupLabels': ['Experimental: Tailored']}, {'name': 'Dispersion ablation + PVI', 'type': 'PROCEDURE', 'description': 'TAILORED-AF index procedure: Dispersion ablation + PVI', 'armGroupLabels': ['Experimental: Tailored']}, {'name': 'PVI', 'type': 'PROCEDURE', 'description': 'TAILORED-AF index procedure: PVI only', 'armGroupLabels': ['Active Comparator: Anatomical']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69677', 'city': 'Bron', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Francis Bessière, MD', 'role': 'CONTACT'}], 'facility': 'CHU Lyon, Hôpital Louis Pradel', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '63050', 'city': 'Clermont-Ferrand', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Antoine Roux, MD', 'role': 'CONTACT'}], 'facility': 'Pôle Santé République', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '59462', 'city': 'Lomme', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Yves Guyomar, MD', 'role': 'CONTACT'}], 'facility': 'Hôpital Saint Philibert', 'geoPoint': {'lat': 50.64358, 'lon': 2.98715}}, {'zip': '13008', 'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Edouard Gitenay, MD', 'role': 'CONTACT'}], 'facility': 'Hôpital Saint-Joseph Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '91300', 'city': 'Massy', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jérôme Horvilleur, MD', 'role': 'CONTACT'}], 'facility': 'Hôpital Privé Jacques Cartier', 'geoPoint': {'lat': 48.72692, 'lon': 2.28301}}, {'zip': '44277', 'city': 'Nantes', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sélim Abbey, MD', 'role': 'CONTACT'}], 'facility': 'Hôpital Privé du Confluent', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '06105', 'city': 'Nice', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Guillaume Théodore, MD', 'role': 'CONTACT'}], 'facility': 'Polyclinique Saint George', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '93207', 'city': 'Saint-Denis', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Antoine Lepillier, MD', 'role': 'CONTACT'}], 'facility': 'Centre Cardiologique du Nord', 'geoPoint': {'lat': 48.93564, 'lon': 2.35387}}, {'zip': '67000', 'city': 'Strasbourg', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Babé Bakouboula, MD', 'role': 'CONTACT'}], 'facility': 'Clinique Rhéna', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31076', 'city': 'Toulouse', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Paul Albenque, MD', 'role': 'CONTACT'}], 'facility': 'Clinique Pasteur', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '54500', 'city': 'Vandœuvre-lès-Nancy', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Christian De Chillou, MD', 'role': 'CONTACT'}], 'facility': 'CHRU Nancy, Institut Lorrain du coeur et des vaisseaux', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}, {'zip': '96450', 'city': 'Coburg', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Mathias Forkmann, MD', 'role': 'CONTACT'}], 'facility': 'Klinikum Coburg', 'geoPoint': {'lat': 50.25937, 'lon': 10.96384}}, {'zip': '80636', 'city': 'Munich', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Isabel Deisenhofer, MD', 'role': 'CONTACT'}], 'facility': 'German Heart Center', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'centralContacts': [{'name': 'Paola MILPIED', 'role': 'CONTACT', 'email': 'paola.milpied@volta-medical.com', 'phone': '(0)768025499', 'phoneExt': '0033'}, {'name': 'Cecile BIELMANN', 'role': 'CONTACT', 'email': 'cecile.bielmann@volta-medical.com'}], 'overallOfficials': [{'name': 'Isabel DEISENHOFER, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Deutsches Herzzentrum Muenchen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Volta Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}