Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-01-08 @ 2:32 PM
Study NCT ID:
NCT06618833
Status:
RECRUITING
Last Update Posted:
2024-10-01
First Post:
2024-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Medical and Sociological Characterization of the Population of Patients Admitted for a First Ablation of Atrial Fibrillation in the Occitanie Ouest Region
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': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-26', 'studyFirstSubmitDate': '2024-09-23', 'studyFirstSubmitQcDate': '2024-09-26', 'lastUpdatePostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Collection of medical and sociological data from the population of patients admitted for a first Atrial Fibrillation Ablation', 'timeFrame': '2 months', 'description': 'Collection of medical data (cardiological, comorbidities, physical and mental health via PROMIS global questionnaire) and sociological data (territorial, economic, professional, ethnic, family). The PROMIS GLOBAL questionnaire is a questionnaire to collect data on the patient\'s general health. It is presented in 10 questions. The answers can vary between "Excellent to Poor", "Totally to Not at All", "Never to Always" or even "None to Very Intense"'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Medical and Sociological Characterization of the Population', 'Global Promis Questionnaire'], 'conditions': ['Fibrillation, Atrial']}, 'descriptionModule': {'briefSummary': 'Atrial fibrillation is the most common arrhythmia with a prevalence of 1 to 4% and constitutes a major health problem both on an individual level (impaired quality of life, heart failure, stroke, hospitalization, excess mortality) and collective level (cost, use of resources).\n\nNon-medical determinants influence health, particularly its cardiovascular component, but have been little studied in the context of Atrial fibrillation. The rare studies addressing the subject suggest that they impact the incidence of the disease and the occurrence of its complications. Certain social and sociological characteristics are also associated with less access to the various recognized therapies, whether medicinal or invasive. This is the case for Atrial fibrillation ablation, which has nevertheless demonstrated its usefulness in reducing the Atrial fibrillation burden, in reducing symptoms and hospitalizations and for certain populations (heart failure) a decrease in mortality.\n\nEssien et al in a literature review report that non-Caucasian and low-income people have less access to Atrial fibrillation ablation. Non-Caucasian populations are also under-represented in interventional clinical studies on Atrial fibrillation. If the level of education (health literacy), geographic origin (rural vs. urban) and the level of isolation affect the occurrence of Atrial fibrillation and its natural history, including complications, the authors do not mention any specific study that has evaluated their role in access to ablation.\n\nA Norwegian national analysis (Olsen) based on data from the health system, therefore exhaustive, evaluated the characteristics of patients suffering from Atrial fibrillation and having benefited from ablation compared to the characteristics of patients treated medically. Patients with the highest levels of education and income are the most likely to be treated by ablation. Women, especially at younger ages, have less access to ablation. The authors also found significant differences between the different territorial subdivisions of the country.', 'detailedDescription': 'There are therefore arguments highlighting the role of non-medical determinants in the management of Atrial fibrillation by ablation. However, they come from studies from countries (USA, Canada, Norway) whose characteristics may not be universally applicable. The investigator can also question the lack of detail of the data that come from national databases and which lack variables to precisely characterize this population. The investigator therefore wish to carry out an observational study aimed at defining on a medical, sociological, economic and territorial level the population having access to Atrial fibrillation ablation in the Occitanie Ouest population basin (represented by the former Midi-Pyrénées region). The data will come from the only two centers performing this type of intervention, the Pasteur clinic and the Toulouse University Hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted for first ablation of Atrial Fibrillation\n\nExclusion Criteria:\n\n* Patients under 18 years of age\n* Pregnancy\n* No coverage by the French health system\n* Refusal to consent\n* History of left atrium ablation'}, 'identificationModule': {'nctId': 'NCT06618833', 'acronym': 'CAMS-AFA', 'briefTitle': 'Medical and Sociological Characterization of the Population of Patients Admitted for a First Ablation of Atrial Fibrillation in the Occitanie Ouest Region', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Medical and Sociological Characterization of the Population of Patients Admitted for a First Ablation of Atrial Fibrillation in the Occitanie Ouest Region', 'orgStudyIdInfo': {'id': 'RC31/23/0539'}, 'secondaryIdInfos': [{'id': '2023-A02755-40', 'type': 'REGISTRY', 'domain': 'ID-RCB Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient admitted for first atrial fibrillation ablation', 'interventionNames': ['Other: Collection of medical data', 'Behavioral: Collection of global health elements', 'Behavioral: PROMIS global questionnaire', 'Behavioral: Collection of sociological data']}], 'interventions': [{'name': 'Collection of medical data', 'type': 'OTHER', 'description': 'Collection of medical data focused on the history of atrial fibrillation by the principal investigator', 'armGroupLabels': ['Patient admitted for first atrial fibrillation ablation']}, {'name': 'Collection of global health elements', 'type': 'BEHAVIORAL', 'description': 'Collection of global health elements (physical and mental) by the principal investigator by discussion with the patient', 'armGroupLabels': ['Patient admitted for first atrial fibrillation ablation']}, {'name': 'PROMIS global questionnaire', 'type': 'BEHAVIORAL', 'description': 'The patient completes the global PROMIS questionnaire which collects data on their overall health.\n\nThe questionnaire consists of 10 questions about the patient\\'s overall health, and for each question, the patient has a possible choice of 5 answers varying between different propositions depending on the question:\n\nExcellent to poor or Totally to not at all, or Always to never or None to very intense', 'armGroupLabels': ['Patient admitted for first atrial fibrillation ablation']}, {'name': 'Collection of sociological data', 'type': 'BEHAVIORAL', 'description': 'Collection of patient sociological data (territorial, economic, professional, ethnic) by the principal investigator', 'armGroupLabels': ['Patient admitted for first atrial fibrillation ablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31000', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Stéphane COMBES, MD', 'role': 'CONTACT', 'email': 'scombes@clinique-pasteur.com', 'phone': '0562211645', 'phoneExt': '+ 33'}, {'name': 'Stéphane COMBES, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinique Pasteur', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '31059', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alexandre DUPARC, MD', 'role': 'CONTACT', 'email': 'duparc.a@chu-toulouse.fr', 'phone': '0561323659', 'phoneExt': '+ 33'}, {'name': 'Olivier LAIREZ, MD', 'role': 'CONTACT', 'email': 'lairez.o@chu-toulouse.fr', 'phone': '0561322873', 'phoneExt': '+33'}, {'name': 'Alexandre DUPARC, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rangueil Hospital', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Alexandre DUPARC, MD', 'role': 'CONTACT', 'email': 'duparc.a@chu-toulouse.fr', 'phone': '0561323659', 'phoneExt': '+ 33'}, {'name': 'Olivier LAIREZ, MD', 'role': 'CONTACT', 'email': 'lairez.o@chu-toulouse.fr', 'phone': '0561322873', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Alexandre DUPARC, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}