A Prospective Randomized Study for the Evaluation of the Impact of Point-by-Point Pulse Field Ablation on Autonomic Nervous System Modulation in Paroxysmal Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Acute HRV variation (PF-only vs. RF-only arm)
研究概览
简要总结
The objective of this clinical trial is to evaluate the impact of pulse field (PF) energy, both alone and in combination with radiofrequency (RF) energy, on vagal modulation during point-by-point pulmonary vein isolation (PVI) in patients with paroxysmal atrial fibrillation (PAF). The effect of PF energy on ganglionated plexi (GP) will be assessed using heart rate variability (HRV) as a surrogate marker. Participants will be randomized into three groups: the PF-only group and the Hybrid group (PF posterior/RF anterior) as the experimental arms, and the RF-only group as the control arm. HRV will be measured before and 24 hours after the PVI procedure. Additionally, cardio and neuro biomarkers (Troponin and S100B) will be measured pre-procedure and 20 minutes post-ablation. All participants will be followed for 12 months, with 24-hour Holter-ECG evaluations scheduled at 3, 6, and 12 months after the initial ablation procedure.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic Paroxysmal Atrial Fibrillation (AF) that terminates spontaneously or with intervention within 7 days of onset
- •Age range: 18-70 years
- •Willing and capable of providing informed consent
- •Able and willing to comply with all pre-, post-, and follow-up testing and requirements
排除标准
- •Previously diagnosed Persistent AF (> 7 days in duration)
- •Previous LA ablation
- •Previous cardiac surgery
- •Myocardial Infarction within the previous 3 months
- •Severely compromised Left Ventricular Ejection Fraction (LVEF<40%)
- •Presence of implanted pacemaker or Implantable Cardioverter-Defibrillator (ICD) or other implanted metal cardiac device that may interfere with the pulsed electric field energy
- •Acute illness, active systemic infection, or sepsis
- •Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation.
- •Severe mitral regurgitation
- •Woman who are pregnant, lactating, or who are planning to become pregnant during the course of the clinical investigation
结局指标
主要结局
Acute HRV variation (PF-only vs. RF-only arm)
时间窗: from enrolment to the day after the ablation procedure
It is the acute difference in the HRV variation (Δ SDNN: baseline/1-day after ablation) between the PF-only arm and the control arm (RF-only).
次要结局
- Acute HRV variation (Hybrid vs. RF-only arm)(from enrolment to the day after the ablation procedure)