Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-01-08 @ 1:03 AM
Study NCT ID:
NCT06497933
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-19
First Post:
2024-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exhaustive French National Registry of AF Ablation Using Pentaspline Pulsed Field Ablation Catheter
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5223}, 'targetDuration': '24 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-17', 'studyFirstSubmitDate': '2024-07-04', 'studyFirstSubmitQcDate': '2024-07-04', 'lastUpdatePostDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'long-term efficacy (AA)', 'timeFrame': 'within 1-year period post-procedure', 'description': 'freedom from all types of atrial arrhythmia recurrences'}, {'measure': 'very long-term efficacy (AA)', 'timeFrame': 'Within 2 years period post-procedure', 'description': 'freedom from all types of atrial arrhythmia recurrences'}], 'secondaryOutcomes': [{'measure': 'long term efficacy (AF)', 'timeFrame': 'within 1-year period post-procedure', 'description': 'freedom from atrial fibrillation recurrences'}, {'measure': 'very long-term efficacy (AF)', 'timeFrame': 'Within 2 years period post-procedure', 'description': 'freedom from atrial fibrillation recurrences'}, {'measure': 'Safety outcomes', 'timeFrame': 'within 1-month post-procedure', 'description': 'the composite of major adverse events, including esophageal complications, symptomatic PV stenosis, cardiac tamponade requiring intervention, stroke or systemic thromboembolism, persistent phrenic nerve injury, vascular access complications requiring surgery, coronary artery spasm, and death'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pulsed field ablation', 'registry'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '40734736', 'type': 'DERIVED', 'citation': 'Chaumont C, Laredo M, Thomas O, Maury P, Massoulie G, Defaye P, Boveda S, Marijon E, Escande W, Roux A, Raczka F, Guyomar Y, Jais P, Ollitrault P, Granier M, Fareh S, Marchand H, Pierre B, Abbey S, Noel A, Da Costa A, Extramiana F, Cesari O, Champ-Rigot L, Khoueiry Z, Villemin T, Traulle S, Treguer F, Bader H, Deharo JC, Degand B, Guy-Moyat B, Klug D, Gandjbakhch E, Zhao A, Beneyto M, Eschalier R, Venier S, Combes S, Lepillier A, Mielczarek M, Clementy N, Menet A, Sacher F, De Chillou C, Anselme F. Countrywide introduction of pulsed field ablation for the treatment of atrial fibrillation: Acute results from the FRANCE-PFA registry. Heart Rhythm O2. 2025 Apr 25;6(7):911-919. doi: 10.1016/j.hroo.2025.04.005. eCollection 2025 Jul.'}]}, 'descriptionModule': {'briefSummary': 'Pulsed field ablation (PFA) is a nonthermal ablative modality using a strong electrical field created around a dedicated catheter to produce pores in the cellular membrane. As the amount of energy required to produce electroporation is highly tissue dependent, the atrial myocardium can be specifically targeted while sparing adjacent tissues. This new ablation modality could increase the safety of pulmonary vein isolation (PVI) procedures compared to PVI using thermal energies. The investigators aim to provide the first exhaustive Nationwide registry using the pentaspline PFA catheter to treat atrial fibrillation patients.', 'detailedDescription': 'This is a multicenter observational research project, that prospectively included patients undergoing a first time atrial fibrillation ablation using the Farapulse technology (Boston Scientific) since the start of this technology in France.\n\nAll patients treated with the Farapulse technology for atrial fibrillation in France from March 2021 to February 29th of 2024 will be included in the registry. The number of participating centers is 33.\n\nA one-year and 2-year follow-up will be performed according to the standard practices of the different centers. The study duration will be 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who underwent for the first time an atrial fibrillation ablation procedure, with pulmonary veins isolation performed with the pentaspline PFA catheter in France will be included in the registry', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients aged ≥18 years\n* Patients who received catheter ablation for paroxysmal AF, persistent AF, or long-standing persistent AF.\n\nExclusion Criteria:\n\n* Previous left atrial ablation.\n* Patient's opposition to participating in this registry"}, 'identificationModule': {'nctId': 'NCT06497933', 'acronym': 'FRANCE-PFA', 'briefTitle': 'Exhaustive French National Registry of AF Ablation Using Pentaspline Pulsed Field Ablation Catheter', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Rouen'}, 'officialTitle': 'Exhaustive French National Online Registry of Atrial Fibrillation Ablation Procedures Using the Pentaspline Pulsed Field Ablation Catheter', 'orgStudyIdInfo': {'id': '2022/0259/OB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Paroxysmal atrial fibrillation patients', 'description': 'patients with paroxysmal atrial fibrillation undergoing first time catheter ablation using the pentaspline PFA catheter', 'interventionNames': ['Procedure: Atrial fibrillation ablation']}, {'label': 'Persistent atrial fibrillation patients', 'description': 'patients with persistent atrial fibrillation undergoing first time catheter ablation using the pentaspline PFA catheter', 'interventionNames': ['Procedure: Atrial fibrillation ablation']}, {'label': 'Long-standing persistent atrial fibrillation patients', 'description': 'patients with long-standing persistent atrial fibrillation undergoing first time catheter ablation using the pentaspline PFA catheter', 'interventionNames': ['Procedure: Atrial fibrillation ablation']}], 'interventions': [{'name': 'Atrial fibrillation ablation', 'type': 'PROCEDURE', 'otherNames': ['Pulsed field ablation procedure using the Faradrive catheter (Boston Scientific)'], 'description': 'Pulmonary veins isolation potentially associated with other atrial lesions, performed with the pentaspline PFA catheter', 'armGroupLabels': ['Long-standing persistent atrial fibrillation patients', 'Paroxysmal atrial fibrillation patients', 'Persistent atrial fibrillation patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76000', 'city': 'Rouen', 'country': 'France', 'facility': 'University Hospital of Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'overallOfficials': [{'name': 'Frederic ANSELME, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Rouen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Rouen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}