Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-25 @ 9:32 PM
Study NCT ID:
NCT03564951
Status:
COMPLETED
Last Update Posted:
2020-09-16
First Post:
2018-06-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ablation of Anisochronous Zones vs Spatio-temporal Dispersal Zones With Antral Electrical Isolation During Radiofrequency Treatment of Paroxysmal or 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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-15', 'studyFirstSubmitDate': '2018-06-11', 'studyFirstSubmitQcDate': '2018-06-20', 'lastUpdatePostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Atrial fibrillation relapse between groups', 'timeFrame': 'Month 18', 'description': 'Atrial fibrillation detected by routine or event-associated Holter examination'}], 'secondaryOutcomes': [{'measure': 'Atrial fibrillation relapse between groups', 'timeFrame': 'Month 12', 'description': 'Atrial fibrillation detected by routine or event-associated Holter examination'}, {'measure': 'Arrhythmia occurrence between groups', 'timeFrame': 'Month 12', 'description': 'Arrhythmia, including atrial tachycardia detected by routine or event-associated Holter examination'}, {'measure': 'Arrhythmia occurrence between groups', 'timeFrame': 'Month 18', 'description': 'Arrhythmia, including atrial tachycardia detected by routine or event-associated Holter examination'}, {'measure': 'Concordance of isochrone and voltage maps', 'timeFrame': 'Day 0', 'description': 'Binary yes/no'}, {'measure': 'Maximum variation of conduction speed between variation healthy zones with anisochronic zones in the same anatomic region', 'timeFrame': 'Day 0'}, {'measure': 'Comparison of the decreasing velocities between healthy zones and anisochronic zones in the same anatomic region', 'timeFrame': 'Day 0'}, {'measure': 'Comparison of wave front rotation between healthy zones and anisochronic zones in the same anatomic region', 'timeFrame': 'Day 0', 'description': 'degrees'}, {'measure': 'Total time of radiofrequency between groups', 'timeFrame': 'Day 0', 'description': 'Minutes'}, {'measure': 'Comparison of lesion volume between groups', 'timeFrame': 'Day 0', 'description': 'Force-time integral, lesion size index or stroke volume index'}, {'measure': 'Total procedure time between groups', 'timeFrame': 'Day 0', 'description': 'Minutes'}, {'measure': 'Number of treated zones between groups', 'timeFrame': 'Day 0'}, {'measure': 'Size of treated zones between groups', 'timeFrame': 'Day 0', 'description': 'cm2'}, {'measure': 'List locations most frequently treated', 'timeFrame': 'Day 0', 'description': 'Number of each'}, {'measure': 'Survival without relapse of the subgroups paroxysmal versus persistent atrial fibrillation.', 'timeFrame': 'Month 18', 'description': 'Atrial fibrillation detected by routine or event-associated Holter examination'}, {'measure': 'Survival without relapse of the subgroups treated using the Carto- vs Rhythmia-guided ablation approaches.', 'timeFrame': 'Month 18', 'description': 'Atrial fibrillation detected by routine or event-associated Holter examination'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'Using isochronous maps during radiofrequency ablation procedures may identify the driver zones responsible for atrial fibrillation maintenance with greater accuracy compared to a conventional procedure (simple antral isolation of the associated pulmonary veins or, if necessary, combined with removal of spatio-temporal dispersal zones) that do not use isochronous maps, and thus improve the efficiency and safety of atrial fibrillation treatment by radiofrequency treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient must have given their free and informed consent and signed the consent form\n* The patient must be a member or beneficiary of a health insurance plan\n* The patient is at least 18 years old\n* The patient has paroxysmal or persistent atrial fibrillation\n* The patient is available for 18 month follow-up\n\nExclusion Criteria:\n\n* The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study\n* The subject refuses to sign the consent\n* It is impossible to give the subject informed information\n* The patient is under safeguard of justice or state guardianship\n* The patient is pregnant or breastfeeding\n* Sinus rhythm has not been able to be determined using external electric cardioversion\n* Patient not susceptible to atrial fibrillation following wide antrum circle ablation\n* The subject has already been included in the study (patients cannot be included more than once)'}, 'identificationModule': {'nctId': 'NCT03564951', 'acronym': 'ISOCHRONE-AF', 'briefTitle': 'Ablation of Anisochronous Zones vs Spatio-temporal Dispersal Zones With Antral Electrical Isolation During Radiofrequency Treatment of Paroxysmal or Persistent Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Comparison of Ablation of Anisochronous Zones vs Spatio-temporal Dispersal Zones in Addition to Antral Electrical Isolation During Radiofrequency Treatment of Paroxysmal or Persistent Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'NIMAO/2017-02/MG-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'ablation of Atrial fibrillation using spatio-temporal dispersion', 'interventionNames': ['Procedure: Atrial fibrillation ablation']}, {'type': 'EXPERIMENTAL', 'label': 'Isochrone', 'description': 'ablation of concordance zones using isochrone and voltage maps', 'interventionNames': ['Procedure: Atrial fibrillation ablation']}], 'interventions': [{'name': 'Atrial fibrillation ablation', 'type': 'PROCEDURE', 'description': 'ablation of Atrial fibrillation using spatio-temporal dispersion', 'armGroupLabels': ['Control']}, {'name': 'Atrial fibrillation ablation', 'type': 'PROCEDURE', 'description': 'ablation of concordance zones using isochrone and voltage maps', 'armGroupLabels': ['Isochrone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'CHU Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU Nimes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}