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Medical and Sociological Characterization of the Population of Patients Admitted for a First Ablation of Atrial Fibrillation in the Occitanie Ouest Region

Medical and Sociological Characterization of the Population of Patients Admitted for a First Ablation of Atrial Fibrillation in the Occitanie Ouest Region

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06618833
Acronym
CAMS-AFA
Enrollment
111
Registered
2024-10-01
Start date
2024-07-22
Completion date
2026-04-27
Last updated
2026-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibrillation, Atrial

Keywords

Medical and Sociological Characterization of the Population, Global Promis Questionnaire

Brief summary

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). Non-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. Essien 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. A 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.

Detailed description

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.

Interventions

Collection of medical data focused on the history of atrial fibrillation by the principal investigator

BEHAVIORALCollection of global health elements

Collection of global health elements (physical and mental) by the principal investigator by discussion with the patient

BEHAVIORALPROMIS global questionnaire

The patient completes the global PROMIS questionnaire which collects data on their overall health. The 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: Excellent to poor or Totally to not at all, or Always to never or None to very intense

BEHAVIORALCollection of sociological data

Collection of patient sociological data (territorial, economic, professional, ethnic) by the principal investigator

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients admitted for first ablation of Atrial Fibrillation

Exclusion criteria

* Patients under 18 years of age * Pregnancy * No coverage by the French health system * Refusal to consent * History of left atrium ablation

Design outcomes

Primary

MeasureTime frameDescription
Collection of medical and sociological data from the population of patients admitted for a first Atrial Fibrillation Ablation2 monthsCollection 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"

Countries

France

Contacts

PRINCIPAL_INVESTIGATORAlexandre DUPARC, MD

University Hospital, Toulouse

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 30, 2026