ABLation-induced Changes in Cardiac Autonomic Nervous System in Patients With Atrial Fibrillation: Radiofrequency Versus Cryoballoon Techniques. The ABLANSAF Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Heart rate-induced changes in the RF and CB groups.
研究概览
简要总结
Aim. To compare changes in cardiac autonomic tone caused by radio-frequency versus cryoballoon ablation and to assess their value in predicting the outcome.
Study group. In this prospective randomized study 126 consecutive patients with paroxysmal AF undergoing first ablation of AF using radio-frequency (RF) or cryoballoon (CB) technique will be recruited. Patients will undergo several ECG and autonomic tests before and after the procedure. The follow-up will last one year.
Measurements:
- Standard 12-lead ECG a day before and 1-2 days after the procedure will be performed. The SR and P wave duration as well as the difference (∆) in SR and P wave duration before and after ablation will be analyzed.
- A 24-hour Holter ECG will be performed at baseline (1-2 days before ablation) and 7-day Holter ECG will be performed 3, 6 and 12 months after the procedure. Minimal, maximal and mean heart rate (HR) as well as HRV parameters will be analyzed. The differences (∆) in these variables between baseline and post-ablation Holter ECG recordings will be analyzed.
- Autonomic parameters (HR, HRV parameters and baroreceptor reflex sensitivity as well as hemodynamic parameters (stroke volume (SV), cardiac output (CO), total peripheral resistance (TPR)) will be also examined before and after orthostatic stress. This will be performed using tilt table test and non-invasive measurement of autonomic and hemodynamic parameters before and shortly after (1-3 days) the procedure.
- Quality of life will be assessed using the AFSS scale and EHRA scale at baseline and 3, 6 and 12 months after ablation.
- Follow-up will last 12 months. Efficacy of ablation will be assessed during outpatients visits and using 7-day Holter ECG recordings 3, 6 and 12 months after the procedure. The analyzed outcomes will include symptomatic recurrences of AF, hospitalizations due to AF, redo procedures i occurrence of asymptomatic AF on Holter ECG monitoring.
- All the above listed parameters and ablation efficacy will be compared between the RF and CB groups.
Anticipated results.
- Ablation significantly effects the parameters of cardiac autonomic control
- These effects are more pronounced in the CB group compared with the RF group
- Changes in autonomic indices have value in predicting ablation efficacy in both analyzed groups.
详细描述
ABLation-induced changes in cardiac Autonomic Nervous System in patients with Atrial Fibrillation: radiofrequency versus cryoballoon techniques (the ABLANSAF study).
Introduction. The primary goal of ablation for atrial fibrillation (AF) is pulmonary vein isolation (PVI). The second mechanism of action of ablation is modification of cardiac autonomic tone by ablation of atrial ganglionated plexi, mainly of their parasympathetic component. Data in literature concerning this topic is scares. A few studies showed that ablation-induced changes in heart rate variability (HRV) or sinus rate (SR) predict the outcome. However, these data are preliminary and have not yet been included into clinical practice. Moreover, whether these effects depend on the technique used - radio-frequency (RF) ablation or cryoballoon (CB) ablation, has not yet been examined.
Aim. To compare the changes in cardiac autonomic tone caused by RF versus CB ablation and to assess their value in predicting the outcome after the procedure.
Hypothesis. We hypothesised that both techniques cause significant changes in cardiac autonomic innervation, however, these changes are significantly more pronounced following CB rather than RF ablation.
Methods. Study group. In this prospective randomised study 126 consecutive patients with paroxysmal AF undergoing first ablation of AF using RF or CB technique will be recruited. Patients will undergo several ECG and autonomic tests before and after the procedure. The follow-up will last one year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Paroxysmal AF
- •First AF ablation
- •Sinus rhythm before and after the procedure at the time of ECG and tilt table testing.
- •No change in medication affecting cardiac autonomic nervous system before and after ablation.
- •Obtained written informed consent to participate in the study.
排除标准
- •Any of inclusion criterion not met
- •Pacing system implanted
- •Additional ablation to PVI like cavo-tricuspid isthmus ablation or linear lesions in the left atrium.
研究组 & 干预措施
RF ablation
Patients treated with point-by-point radio-frequency ablation
干预措施: Radio-frequency ablation (Procedure)
Cryoballoon ablation
Patients treated with cryoballoon ablation
干预措施: Cryoballoon ablation (Procedure)
结局指标
主要结局
Heart rate-induced changes in the RF and CB groups.
时间窗: 1-2 days before and 2-3 days after ablation heart rate will be recorded
The baseline and tilt-induced heart rate (beats/min) measured before and after ablation will be compared between the RF and CB groups
Heart rate variability (SDNN)-induced changes in the RF and CB groups.
时间窗: 1-2 days before and 2-3 days after ablation SDNN parameter will be recorded
The baseline and tilt-induced heart rate variability (SDNN) (msec) measured before and after ablation will be compared between the RF and CB groups
Baroreflex sensitivity-induced changes in the RF and CB groups.
时间窗: 1-2 days before and 2-3 days after ablation baroreflex sensitivity will be recorded
The baseline and tilt-induced baroreflex sensitivity (msec/mmHg) measured before and after ablation will be compared between the RF and CB groups
次要结局
- Ablation-induced changes in heart rate predicting ablation efficacy(One year)
- Ablation-induced changes in baroreflex sensitivity predicting ablation efficacy(One year)
- Efficacy of RF versus CB ablation (ECG symptomatic AF recurrences)(One year)
- Ablation-induced changes in heart rate variability predicting ablation efficacy(One year)
研究者
Prof. Piotr Kulakowski
Professor, head of Electrophysiology Department
Centre of Postgraduate Medical Education