The Impact of Cryoablation Using Expandable (POLARxFIT) vs. Standard Size (POLARx) Balloon on Autonomic Control of the Heart
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- difference in the rate of persistent parasympathetic modulation
研究概览
简要总结
Approximately 40% of patients following cryoballoon ablation show signs of parasympathetic denervation. The presence of such effect is related to better outcomes in terms of clinical efficacy (freedom from atrial fibrillation). It could be hypothesized that larger sized balloon (POLARxFIT system) because of more antral position within the left atrium (and hence smaller distance from ganglionated plexi) might enhance this beneficial modulation of the autonomic system of the heart. This study intends to compare the effects of cryoablation employing expandable balloon (POLARxFIT) vs. standard balloon (POLARx) on autonomic system of the heart.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary PVI
- •paroxysmal atrial fibrillation
- •sinus rhythm at the admission
- •participant meets clinical criteria for PVI
排除标准
- •LA diameter <38 mm or >50 mm
- •LVEF <40%
- •intrinsic sinus node disease
- •advanced atrioventricular block (PR interval >300 ms, II or III degree AV block)
- •previous cardioneuroablation procedure
- •pregnancy
- •contraindications to anticoagulation treatment
- •any other clinical contraindications to PVI
- •known atropine intolerance
研究组 & 干预措施
expandable cryoballoon
POLARxFIT
干预措施: cryoablation of atrial fibrillation using expandable balloon (28 / 31 mm) (Device)
standard cryoballoon
POLARx
干预措施: cryoablation of atrial fibrillation using only 28 mm size balloon (Device)
结局指标
主要结局
difference in the rate of persistent parasympathetic modulation
时间窗: 3 months
defined as decrease in RR interval of \>20%
次要结局
- difference in time to first AF episode(12 months)
- difference in radiation dose(periprocedural)
- difference in left atrial dwell time(periprocedural)
- difference in contrast volume(periprocedural)
研究者
Piotr Niewinski, MD
Principal Investigator
Wroclaw Medical University