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

NCT06618833 | Recruiting

• 2 other identifiers: RC31/23/05392023-A02755-40
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Fibrillation, Atrial

Keywords

Medical and Sociological Characterization of the Population; Global Promis Questionnaire

Outcome Measures

Primary Outcomes (1)

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

  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"

  2 months

Study Arms (1)

Patient admitted for first atrial fibrillation ablation

EXPERIMENTAL

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

Interventions

Collection of medical data OTHER

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

Patient admitted for first atrial fibrillation ablation

Collection of global health elements BEHAVIORAL

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

Patient admitted for first atrial fibrillation ablation

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

Patient admitted for first atrial fibrillation ablation

Collection of sociological data BEHAVIORAL

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

Patient admitted for first atrial fibrillation ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted for first ablation of Atrial Fibrillation

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (2)

Clinique Pasteur

Toulouse, 31000, France

RECRUITING

Rangueil Hospital

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexandre DUPARC, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandre DUPARC, MD

CONTACT

0561323659; duparc.a@chu-toulouse.fr

Olivier LAIREZ, MD

CONTACT

0561322873; lairez.o@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: October 1, 2024
• Study Start: July 22, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)