First in Man Study of Pulsed Field Ablation System for the Treatment of Paroxysmal Atrial Fibrillation in 1 Patient
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The effectiveness of the pulsed field ablation system in the treatment of paroxysmal atrial fibrillation is evaluated by the 12-month ablation success rate of atrial fibrillation.
研究概览
简要总结
This is the first in man study of CadioPulseTM ( pulsed field ablation system) developed and manufactured by Hangzhou Dinova EP Technology Co., Ltd, which can be used for Pulmonary vein isolation for the treatment of paroxysmal atrial fibrillation. This study aims to initially verify the safety and efficacy of the device.
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
- •Patients aged 18 to 75 years old;
- •Patients diagnosed with symptomatic paroxysmal atrial fibrillation: (The medical records documented recurrent and self-terminating atrial fibrillation).Electrocardiographic recordings may include, but are not limited to, electrocardiography (ECG), ambulatory ECG monitoring, or telemetric ECG.
- •Capable and willing to comply with all preoperative and postoperative follow-up examinations and requirements.
- •Able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the subject him/herself.
排除标准
- •AF secondary to electrolyte imbalance, thyroid disease, or reversible cause;
- •AF episodes lasting more than 7 days;
- •History of previous AF ablation therapy;
- •Previous valve repair, replacement or artificial valve implantation; previous atrial septal defect closure, patent foramen ovale closure cardiac intervention or surgery;
- •Any myocardial infarction (MI), coronary artery bypass grafting (CABG) procedure or percutaneous coronary intervention (PCI) during the 3-month interval preceding the consent date;
- •Hypertrophic Obstructive Cardiomyopathy (HOCM);
- •NYHA class III and IV;
- •Presence of implanted ICD, CRT;
- •Documented active thrombus in the left atrium or atrial appendage on imaging;
- •Any carotid artery stent implantation or endarterectomy within the previous 6 months;
- •Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gas or severe breathing difficulties;
- •Known pulmonary vein stenosis
- •Contraindication to isoproterenol therapy.
- •Anticoagulation contraindications, and history of blood clotting or bleeding abnormalities;
- •Patients with acute systemic infection;
- •（eGFR）< 60mL/min/1.73m2, or have a history of kidney dialysis;
- •Women who are pregnant and/or breast feeding or unable to use contraception during the trial;
- •Enrollment in another clinical trial evaluating other devices or drugs during the same period;
- •Life expectancy less than 12 months (such as patients with advanced cancer);
- •Abnormalities or diseases that the investigator considers to be excluded from the study's coverage.
研究组 & 干预措施
Device: CardioPulse PFA system
Pulmonary vein isolation(PVI) was performed with the novel hex spline PFA ablation catheter( CardioPulseTM PFA system, Hangzhou Dinova EP Technology Co., Ltd).
干预措施: CardioPulsesTM pulsed field ablation system (Device)
结局指标
主要结局
The effectiveness of the pulsed field ablation system in the treatment of paroxysmal atrial fibrillation is evaluated by the 12-month ablation success rate of atrial fibrillation.
时间窗: 12 months after the ablation
12-month ablation success rate of atrial fibrillation is defined by ECG data (including ECG and 24-hour dynamic electrocardiogram (Holter)) during the effective evaluation period (blanking period to the end of 12-month follow-up), without recording AF, AFL or AT (Arrhythmia monitoring device ≥ 30 seconds).
次要结局
- Acute isolation success rate(30 minutes after the ablation)
- The rate of repeat ablation within 12 months.(12 months after the ablation)
- Incidence of device-related or operating-related major adverse events (MAE) 3 months after surgery(3 months after the ablation)
- Procedure efficiency(immediately after the ablation)