Cryoablation With Vestibular Expansion for the Treatment of Paroxysmal/Short-course Persistent Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- pulmonary vein isolation rate
研究概览
简要总结
The purpose of this study was to verify the safety and efficacy of routine and extended vestibular ablation in the treatment of paroxysmal/short-course persistent atrial fibrillation.
详细描述
The purpose of this study was to verify the safety and efficacy of routine and extended vestibular ablation using the Medtronic Arctic Front AdvanceTM catheter in the treatment of paroxysmal/short-course persistent atrial fibrillation
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old ≤ age ≤ 85 years old;
- •Patients with paroxysmal/short-term persistent atrial fibrillation;
- •Be able to understand the purpose of the research, voluntarily participate in the research and sign the informed consent.
排除标准
- •Echocardiography shows that the left atrium diameter is greater than or equal to 45mm;
- •Preoperative CT or esophageal echocardiography suggests that there is a thrombus in the left atrium/left atrial appendage;
- •Those who have undergone left atrial ablation or left atrial surgery;
- •Those who have received simple left atrial appendage occlusion;
- •New York heart function class (NYHA) class III or IV congestive heart failure or LVEF (%) less than 40%;
- •Those who have undergone valve repair;
- •Preoperative electrocardiogram or Holter confirmed the presence of typical atrial flutter or other supraventricular tachycardia (holding The duration is greater than 30 s);
- •Secondary atrial fibrillation, including uncontrolled hyperthyroidism, acute alcoholism, cardiac surgery postoperative atrial fibrillation, etc.;
- •History of acute coronary events or percutaneous coronary stent intervention within 6 months before enrollment;
- •Those with a history of cardioverter-defibrillator (ICD) implantation or a history of cardiac resynchronization therapy (CRT);
- •History of stroke or transient ischemic attack within 6 months before enrollment;
- •Those with obvious bleeding tendency who cannot receive postoperative systemic anticoagulation;
- •Severe structural heart disease, including moderate to severe mitral insufficiency or stenosis, previous myocardial infarction, hypertrophic cardiomyopathy, etc.;
- •Combined with other serious diseases, the life expectancy is less than 12 months;
- •Women who are pregnant, breastfeeding and planning to become pregnant;
- •Have participated in or are participating in clinical investigators of other drugs or devices within 3 months before enrollment;
- •Other conditions assessed by the investigator to be unsuitable for inclusion in this study, such as persons with mental disorders or mental disorders.
研究组 & 干预措施
Vestibule Group
Cryoablation
干预措施: cryoablation (Device)
结局指标
主要结局
pulmonary vein isolation rate
时间窗: Immediate
Immediate success rate of surgery: the percentage of subjects whose pulmonary veins were successfully electrically isolated at the end of surgery (including 30-minute observation time) to the total number of patients undergoing surgery.
1-year atrial fibrillation-free rate
时间窗: 1-year
Treatment success rate within 12 months after surgery (ie: no antiarrhythmic drug use, and no atrial fibrillation lasting ≥30s after a 3-month postoperative blank period to a 12-month postoperative follow-up). , AF), Atrial Flutter (AFL) or Atrial Tachycardia (AT) events).
次要结局
未报告次要终点
研究者
Ya-Wei Xu
Director
Shanghai 10th People's Hospital