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:
University Hospital, Toulouse
Organization:
Study Overview
Official Title:
Medical and Sociological Characterization of the Population of Patients Admitted for a First Ablation of Atrial Fibrillation in the Occitanie Ouest Region
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAMS-AFA
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2023-A02755-40 | REGISTRY | ID-RCB Number | View |