Navi-Star Thermo-Cool Catheter For Ablation of Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 2
- 主要终点
- Atrial Tachyarrhythmia Recurrence in Participants
研究概览
简要总结
The objective of this study is to demonstrate that the NAVI-STAR THERMO-COOL catheter can be used to safely and effectively reduce symptomatic episodes of paroxysmal atrial fibrillation in patients with frequent (>3 episodes/month) or infrequent <3 episodes/month)atrial fibrillation resistant to at least one Class I or Class III antiarrhythmic drug.
详细描述
The ability of a saline irrigated catheter to deliver RF energy at higher power with a lower electrode-tissue interface temperature, combined with the anatomical guidance of electroanatomical mapping should allow:
- Isolation of the pulmonary veins at the LA-PV junction with the same or lower risk of pulmonary vein stenosis;
- Creation of continuous, transmural linear left atrial lesions with the same or lower risk of thromboembolism;
- These two factors will eliminate documented episodes of symptomatic sustained AF in patients with frequent (>3 episodes/month) or infrequent (<3 episodes/month);
- Patients with interruption of the vagal response (sinus bradycardia or AV block) during stimulation at the sites of left atrial autonomic ganglionated plexi (GP) will have lower recurrence of 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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater or equal to 18 years
- •At least one documented episode of atrial fibrillation (AF) within the previous 6 months.
- •Failure of at least one antiarrhythmic drug (Class I or III) defined as recurrence of AF or adverse effect.
- •Informed consent obtained.
排除标准
- •Left atrial thrombus
- •Acute myocardial infarction within eight (8) weeks
- •Atriotomy within eight (8) weeks
- •Decompensated heart failure (unless the AF is thought to be a significant etiologic factor and AF ablation is clinically indicated)
- •Ablation in a pulmonary vein within 4 months.
- •Occurrence of perforation during an ablation procedure performed less than two months prior to the planned ablation date.
- •Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in the study.
- •Enrolled in an investigational study evaluating another device or drug
- •Unwilling to participate in the study or unavailable for follow-up visits.
- •Incarcerated
结局指标
主要结局
Atrial Tachyarrhythmia Recurrence in Participants
时间窗: 0-5 years
Outcome is determined by recurrence of atrial tachyarrhythmia in participants. Outcome is measured by any atrial tachyarrhythmias recorded by 12-lead ECGs, Holter monitoring or event monitoring. Recurrence of atrial tachyarrhythmia is also measured by symptoms reported by patients. Symptoms include palpitations, dizziness, dyspnea and any AF-related symptoms that existed before AF ablation.
次要结局
- Total Number of Significant Ablation Procedure Related Complications(0-1 year)