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临床试验/NCT06618833
NCT06618833已完成不适用

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

University Hospital, Toulouse4 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2024年7月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
111
试验地点
4
主要终点
Collection of medical and sociological data from the population of patients admitted for a first Atrial Fibrillation Ablation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients admitted for first ablation of Atrial Fibrillation

排除标准

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

研究组 & 干预措施

Patient admitted for first atrial fibrillation ablation

Experimental

干预措施: Collection of medical data (Other)

Patient admitted for first atrial fibrillation ablation

Experimental

干预措施: Collection of global health elements (Behavioral)

Patient admitted for first atrial fibrillation ablation

Experimental

干预措施: PROMIS global questionnaire (Behavioral)

Patient admitted for first atrial fibrillation ablation

Experimental

干预措施: Collection of sociological data (Behavioral)

结局指标

主要结局

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

时间窗: 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"

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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