Baroreflex Sensitivity in Patients Undergoing Atrial Fibrillation Ablation: Association With Arrhythmia Recurrences
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Mean slope assessed before ablation in the recurrence and the non-recurrence groups
研究概览
简要总结
Atrial fibrillation is the most common arrhythmia. The posterior surface of the left atrium is covered by an extensive network belonging to the autonomic nervous system that can be damaged during the ablation. The involvement of the autonomous nervous system in the genesis and maintenance of atrial fibrillation remains poorly understood. Baroreflex sensitivity is a non-invasive method assessing autonomous nervous system activity.
The rate of atrial fibrillation recurrence after ablation is currently high and a better understanding of the mechanisms associated with recurrence is essential to improve selection of the patients who will benefit the most from this procedure.
The aim of this study is to evaluate the association between the baroreflex sensitivity and atrial fibrillation recurrences and to analyze the prognostic contribution of the baroreflex measurement compared to other published criteria.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old,
- •Patients with paroxysmal atrial fibrillation, hospitalized for atrial fibrillation ablation,
- •Assessable baroreflex sensitivity before ablation,
- •Free subject, without guardianship or curatorship or subordination,
- •Patients benefiting from a Social Security assurance,
- •Informed consent signed by the patient after clear and fair information about the study.
排除标准
- •Age < 18,
- •History of atrial fibrillation ablation,
- •Inability to calculate the baroreflex sensitivity
- •Contraindication to the performance of a cardiac CT scan (allergy to iodine, severe renal insufficiency with clearance <30 ml/mn/m2),
- •Inability to have continuous ECG recording by subcutaneous Holter,
结局指标
主要结局
Mean slope assessed before ablation in the recurrence and the non-recurrence groups
时间窗: Recurrence is assessed at one year of follow-up
To compare baroreflex sensitivity assessed by mean Slope 1 month before the ablation in the recurrence group at 1 year and in the no AF recurrence group at 1 year.
次要结局
- Baroreflex sensitivity fall between the groups with and without AF recurrence(Recurrence is assessed at one year of follow-up)
- Association between baroreflex sensitivity assessed before ablation and atrial fibrillation burden(Burden is assessed at one year of follow-up)
- Quality of life(before and at one year after atrial fibrillation ablation)
- Evolution of baroreflex sensitivity(Before, day 1 and month 3 after the ablation)
- Biological and imaging parameters(Burden is assessed at one year of follow-up)