Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:27 AM
Study NCT ID:
NCT03564327
Status:
COMPLETED
Last Update Posted:
2025-12-22
First Post:
2018-06-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Prognosis of Patients With Atrial Fibrillation During Radiofrequency Ablation
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 175}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-09-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2018-06-11', 'studyFirstSubmitQcDate': '2018-06-11', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Atrial fibrillation relapse in non-reducible or non-inducible patients', 'timeFrame': 'Month 18', 'description': 'Atrial fibrillation detected by routine or event-associated Holter examination'}], 'secondaryOutcomes': [{'measure': 'Atrial fibrillation relapse in non-reducible or non-inducible patients', 'timeFrame': 'Month 12', 'description': 'Atrial fibrillation detected by routine or event-associated Holter examination'}, {'measure': 'Arrhythmia occurrence in non-reducible or non-inducible patients', 'timeFrame': 'Month 12', 'description': 'Arrhythmia, including atrial tachycardia detected by routine or event-associated Holter examination'}, {'measure': 'Arrhythmia occurrence in non-reducible or non-inducible patients', 'timeFrame': 'Month 18', 'description': 'Arrhythmia, including atrial tachycardia detected by routine or event-associated Holter examination'}, {'measure': 'Identification of zones of low voltage on voltage maps in non-inducible patients', 'timeFrame': 'Day 0', 'description': 'Yes/No'}, {'measure': 'Identification of zones of anisochronic zones on voltage maps in non-inducible patients', 'timeFrame': 'Day 0', 'description': 'Yes/No'}, {'measure': 'Maximum variation of conduction speed in the same anatomic region in non-inducible patients', 'timeFrame': 'Day 0', 'description': '%'}, {'measure': 'Decreasing velocities in the same anatomic region in non-inducible patients', 'timeFrame': 'Day 0', 'description': '%'}, {'measure': 'Wave front rotation in the same anatomic region in non-inducible patients', 'timeFrame': 'Day 0', 'description': 'degrees'}, {'measure': 'Total time of radiofrequency in non-inducible patients', 'timeFrame': 'Day 0', 'description': 'Minutes'}, {'measure': 'Total procedure time in non-inducible patients', 'timeFrame': 'Day 0', 'description': 'Minutes'}, {'measure': 'Comparison of lesion volume in non-inducible patients', 'timeFrame': 'Day 0', 'description': 'Force-time integral, lesion size index or stroke volume index'}, {'measure': 'Number and size of treated zones by guided versus conventional ablation in non-inducible patients', 'timeFrame': 'Day 0', 'description': 'cm2'}, {'measure': 'List locations most frequently treated', 'timeFrame': 'Day 0', 'description': 'Number of each'}, {'measure': 'Survival without relapse of patients treated using the Carto- vs Rhythmia-guided ablation approaches in non-reducible or non-inducible patients', 'timeFrame': 'Month 18', 'description': 'Atrial fibrillation detected by routine or event-associated Holter examination'}, {'measure': 'Arrhythmia occurrence in non-reducible or non-inducible patients', 'timeFrame': 'Month 18', 'description': 'Atrial fibrillation detected by routine or event-associated Holter examination'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'Identify the parameters of the predictive isochronous map for the clinical outcome of radiofrequency ablation in terms of absence of documented atrial fibrillation recurrence at 18 months.'}, '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 is available for 18 month follow-up\n* The patient has paroxysmal or persistent atrial fibrillation\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 Early Study Exit Criteria: Patient does not have paroxysmal or persistent AF at the time of inclusion'}, 'identificationModule': {'nctId': 'NCT03564327', 'acronym': 'Isochrone-AFAn', 'briefTitle': 'Clinical Prognosis of Patients With Atrial Fibrillation During Radiofrequency Ablation', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Clinical Prognosis of Patients With Atrial Fibrillation During Radiofrequency Ablation and Interest of the Isochron Map', 'orgStudyIdInfo': {'id': 'NIMAO/2017-03/MG-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patients with atrial fibrillation', 'interventionNames': ['Procedure: External electric cardioversion']}], 'interventions': [{'name': 'External electric cardioversion', 'type': 'PROCEDURE', 'description': 'Three attempts (200-250 joules)', 'armGroupLabels': ['patients with atrial fibrillation']}]}, '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}}], 'overallOfficials': [{'name': 'Mathieu Granier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Montpellier'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}