The Effect and Safety of Pulsed Field Ablation (PFA) in Patients With Paroxysmal Atrial Fibrillation (PAF)-A Prospective Multicenter Single-arm Study
试验速览
- 阶段
- 不适用
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Immediate success rate
研究概览
简要总结
This study is aimed to evaluate the Efficacy and Safety of Pulsed Field Ablation (PFA) in Patients with Paroxysmal Atrial Fibrillation (PAF)
详细描述
This clinical trial is a prospective, multi-center and single-arm Study. It will be carried out in 3 or more clinical trial institutions, and eligible patients with paroxysmal atrial fibrillation are enrolled. For those patients recruited, pulmonary vein isolation will be performed using pulsed field ablation device (Sichuan Jinjiang Electronic Technology Co., Ltd. Chengdu, China). The safety and efficacy of pulsed field ablation(PFA) in Patients with Paroxysmal Atrial Fibrillation (PAF) will be studied using ring-shaped pulsed field ablation catheter
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Paroxysmal Atrial Fibrillation (PAF)
排除标准
- •A history of atrial fibrillation ablation;
- •Left ventricular ejectfraction(LVEF)<35%
- •Left Atrium(LA)（echocardiography）>55mm
- •Thrombus in the left atrial or heart before surgery
- •New York Heart Association(NYHA) grade Ⅲ-Ⅳ
- •second or third degree atrioventricular block
- •Significant congenital heart defects (e.g. atrial septal defect or severe pulmonary vein stenosis, but except foramen ovale)
- •Prosthetic valves
- •Pacemakers or defibrillators (ICD)
- •Hypertrophic cardiomyopathy, chronic obstructive pulmonary disease or myxoma
- •Symptomatic carotid stenosis
- •Untreated or uncontrolled hyperthyroidism or hypothyroidism
- •Systemic active infection
- •Renal failure with obvious bleeding tendency or undergoing hemodialysis
- •Myocardial infarction or any cardiac intervention/open surgery within 3 months
- •Stroke or transient ischemic attack within 6 months
- •Obvious contraindication for interventional surgery who were determined by the investigator to be unable to undergo ablation
- •Pregnant or lactating women or those who planned to have a family during the study period
- •Have participated in clinical trials of other drugs or medical devices within 3 months
- •Unsuitable to participate in this clinical trial by the investigator
结局指标
主要结局
Immediate success rate
时间窗: during procedure
Procedural success for PAF is defined as the achievement of complete pulmonary venous electrical isolation
次要结局
- Procedural success rate at 12 months after procedure(between 3 months and 12 months after ablation)
- The occurrence of hospitalizations or emergency department visit due to symptoms of atrial arrhythmia at 6-month and 12-month follow-up(at 6-month and 12-month)
- Evaluation of a disposable cardiac pulsed electric field ablation catheter(baseline)
- Evaluation of pulsed electric field ablation instrument(baseline)