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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 (CAMS-AFA)

T

Toulouse University Hospital

Status

Enrolling

Conditions

Fibrillation, Atrial

Treatments

Behavioral: Collection of global health elements
Other: Collection of medical data
Behavioral: PROMIS global questionnaire
Behavioral: Collection of sociological data

Study type

Interventional

Funder types

Other

Identifiers

NCT06618833
2023-A02755-40 (Registry Identifier)
RC31/23/0539

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

Patient admitted for first atrial fibrillation ablation
Experimental group
Treatment:
Behavioral: Collection of sociological data
Behavioral: PROMIS global questionnaire
Other: Collection of medical data
Behavioral: Collection of global health elements

Trial contacts and locations

3

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Central trial contact

Alexandre DUPARC, MD; Olivier LAIREZ, MD

Data sourced from clinicaltrials.gov

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