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临床试验/NCT06039722
NCT06039722已完成不适用

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.

Shenzhen Pulsecare Medical Technology Co., Ltd.1 个研究点 分布在 1 个国家目标入组 166 人开始时间: 2022年11月3日最近更新:
适应症

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:

  1. Immediate success rate of surgery Immediately success of the surgery: complete pulmonary vein electrical isolation was achieved after ablation.
  2. Immediate success rate of surgery=number of patients with immediate success of surgery/number of cases in subjects × 100%
  3. 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:

  1. The occurrence of hospitalization or emergency treatment due to symptoms caused by atrial arrhythmias during follow-up at 6 and 12 months after surgery;
  2. Device performance evaluation;

Safety evaluation indexes:

  1. The occurrence of death, stroke, or transient ischemic attack;
  2. 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;
  3. Clinically significant vital signs and related examinations;
  4. 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

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)

研究者

发起方
Shenzhen Pulsecare Medical Technology Co., Ltd.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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