Prospective, Multicenter, Single-arm Clinical Trial Evaluating the Safety and Efficacy of the Pulse Field Ablation System in Combination With the Pulse Field Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- Immediate success rate of surgery
研究概览
简要总结
This study is expected to include 166 subjects and Conducted at 11 research centers;The expected 12 month treatment success rate of using research instruments is 65%.
Principle evaluation indexes:
- Immediate success rate of surgery Immediately success of the surgery: complete pulmonary vein electrical isolation was achieved after ablation.
- Immediate success rate of surgery=number of patients with immediate success of surgery/number of cases in subjects × 100%
- Treatment success rate at 12 months after surgery Treatment success: Between 3 months and 12 months after ablation, there were no episodes of atrial fibrillation/atrial flutter/atrial tachycardia (duration ≥ 30 seconds, with clear electrocardiogram confirmation) without the use of antiarrhythmic drugs.
Treatment success rate=number of successful cases of postoperative treatment in subjects/number of cases in subjects × 100%
Secondary evaluation indexes:
- The occurrence of hospitalization or emergency treatment due to symptoms caused by atrial arrhythmias during follow-up at 6 and 12 months after surgery;
- Device performance evaluation;
Safety evaluation indexes:
- The occurrence of death, stroke, or transient ischemic attack;
- The occurrence of surgical related complications, such as vascular puncture complications (pseudoaneurysm, arteriovenous fistula, etc.), heart perforation, atrial esophageal fistula, phrenic nerve injury, pulmonary vein stenosis (symptomatic), etc;
- Clinically significant vital signs and related examinations;
- The occurrence of other adverse events and serious adverse events during the trial period.
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 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet all of the following conditions to be enrolled:
- •18 to 80 years of age, gender is not limited
- •Patients with a clinical diagnosis of paroxysmal atrial fibrillation confirmed by ECG
- •Patients who were to undergo catheter ablation of atrial fibrillation
- •Those who agreed to participate in this study and voluntarily signed the informed consent form
排除标准
- •Subjects were excluded if they met one of the following conditions:
- •Patients who have had ablation for atrial fibrillation
- •Patients with left ventricular ejection fraction (LVEF) <35%.
- •Patients with an anteroposterior diameter of the left atrium (echocardiography) >50 mm
- •Preoperative detection of a definite thrombus in the left atrium
- •Patients with cardiac function class (NYHA) III-IV
- •Patients with second-degree (type II) or third-degree atrioventricular block
- •Patients with significant congenital heart defects (including atrial septal defect, ventricular septal defect, arterial ductus arteriosus, transposition ofthe grea, or severe pulmonicvalve, but not including foramen ovale persistens)
- •Patients with implanted prosthetic valves or the presence of severe heart valve disease, who are not suitable for ablation for atrial fibrillation
- •Patients with artificial cardiac pacemaker or implantable cardioverter defibrillator (ICDs)
- •Patients diagnosed with hypertrophic obstructive cardiomyopathy, chronic obstructive pulmonary disease, or myxoma
- •Patients who need to undergo left atrial appendage closure in the same surgery
- •Patients found to have atrial flutter preoperatively and judged unsuitable by the investigators, or patients with atrial parasystolic tachycardia (non-pulmonary venous origin) or paroxysmal supraventricular tachycardia
- •Patients with active systemic infection who are judged unsuitable for interventional therapy by the investigators
- •Patients with systemic bleeding tendencies that preclude surgery or patients with renal failure undergoing hemodialysis
- •Patients who have had a myocardial infarction or any interventional/open heart surgery (except coronary angiography) within 3 months
- •Patients who have had a stroke (except asymptomatic stroke) or transient ischemic attack within 3 months
- •Patients with significant contraindications to interventional procedures or with an expected survival of <1 year who are judged by the investigator to be incapable of undergoing ablative procedures
- •Females who are pregnant or breastfeeding or who are planning to have children during the study period
- •Patients who have participated in a clinical trial of another drug or medical device within 3 months
- •Patients who, in the opinion of the investigator, are not suitable for participation in this clinical trial
结局指标
主要结局
Immediate success rate of surgery
时间窗: After surgery 20 minutes later
Immediate success rate of surgery Immediately success of the surgery: complete pulmonary vein electrical isolation was achieved after ablation. Immediate success rate of surgery Immediately success of the surgery: complete pulmonary vein electrical isolation was achieved after ablation. Immediate success rate of surgery Immediately success of the surgery: complete pulmonary vein electrical isolation was achieved after ablation. Immediate success rate of surgery=number of patients with immediate success of surgery/number of cases in subjects × 100%
Treatment success rate
时间窗: Between 3 months and 12 months after ablation
Treatment success rate at 12 months after surgery Treatment success: Between 3 months and 12 months after ablation, there were no episodes of atrial fibrillation/atrial flutter/atrial tachycardia (duration ≥ 30 seconds, with clear electrocardiogram confirmation) without the use of antiarrhythmic drugs. Treatment success rate=number of successful cases of postoperative treatment in subjects/number of cases in subjects × 100%
次要结局
- numer of cases of the the occurrence of hospitalization or emergency treatment(Between 0 months and 12 months after ablation)
- Device performance evaluation(surgery period)
