jRCT1032230199招募中不适用
Real-world Assessment of QDOT MICRO Catheter-based Pulmonary Vein Isolation with Therapeutic Strategy for Persistent Atrial Fibrillation
Johnson & Johnson K.K. Medical Company0 个研究点目标入组 1,000 人开始时间: 2023年7月31日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 主要终点
- Incidence of Primary Adverse Events (PAEs)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Subject must meet ALL of the following inclusion criteria to be eligible for enrollment into the study:
- •1.Signed and dated the informed consent form.*
- •2.Diagnosed with drug refractory symptomatic persistent atrial fibrillation lasting longer than 7 days but less than or equal to 12 months
- •3.Indicated for AF ablation for symptomatic persistent atrial fibrillation according to the latest version of JCS/JHRS guidelines (at investigators discretion).
- •4.Scheduled to undergo AF ablation for treatment of their persistent AF using QDOT MICRO catheter
- •5.Age 18 years or older
- •6.Able and willing to comply with all pre-, post- and follow-up testing and requirement as per hospital standard of care
- •When a legal representative of the subject signs the consent, his/her legally acceptable representative must have signed and dated the informed consent form.
排除标准
- •Subjects must not meet ANY of the following exclusion criteria to be eligible for enrollment into the study:
- •1.Previous surgical or catheter ablation for atrial fibrillation.
- •2.Presenting any contra-indication for the use of QDOT MICRO catheter, as indicated in the IFU
- •3.Women of childbearing potential who are, or plan to become, pregnant during the study
- •4.Not expected to participate in the study for 12-month follow up post-procedure.
- •5.Currently enrolled or planning to participate in any interventional study
- •6.Uncontrolled heart failure or New York Heart Association (NYHA) function class IV
- •7.Life expectancy of less than 12 months
结局指标
主要结局
Incidence of Primary Adverse Events (PAEs)
时间窗: 7 days post index procedure
Incidence of Primary Adverse Events (PAEs) related to the device and/or procedure occurring within 7 days post index procedure.
Freedom from documented asymptomatic and symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) episodes
时间窗: 91-365 days post index procedure
Freedom from documented asymptomatic and symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) episodes based on electrocardiographic data (episodes >=30 seconds).
次要结局
未报告次要终点