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OpenTrials
Completed

NCT Number: NCT06618833

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Pasteur, Toulouse, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collection of medical data

Other

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

Collection of global health elements

Behavioral

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

PROMIS global questionnaire

Behavioral

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

Collection of sociological data

Behavioral

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

Primary outcomes

  1. Collection of medical and sociological data from the population of patients admitted for a first Atrial Fibrillation Ablation

    Time frame: 2 months

    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"

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: CAMS-AFA

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 1, 2024
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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