Clinical Evaluation of Therapy™ Cool Flex Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- Procedural parameters
研究概览
简要总结
The purpose of this study is to observe the performance of Therapy™ Cool Flex™ catheter by documenting the procedural parameters, major complications and recurrence of AF after ablation using Cool Flex ablation catheter for the treatment of paroxysmal atrial fibrillation.
This study is an observational clinical study which is not based on any specific endpoints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A signed written Informed Consent form
- •18 years of age or older
- •Agrees to comply with follow-up visits and evaluation
- •Candidate for catheter ablation for the treatment of paroxysmal atrial fibrillation as per the hospital standard of care.
排除标准
- •Persistent or Long standing AF
- •CABG procedure within the last 180 days (six months).
- •Documented left atrial thrombus on imaging [e.g. Transesophageal echocardiogram (TEE)].
- •History of blood clotting or bleeding abnormalities.
- •Contraindication to anticoagulation (i.e. heparin or warfarin).
- •Enrollment in another investigational study evaluating device or drug that might impact the results of this study.
- •Women who are pregnant (by history of menstrual period or pregnancy test if the history is considered unreliable).
- •Acute illness or active systemic infection or sepsis.
- •Life expectancy less than 12 months.
- •Uncontrolled heart failure or NYHA class IV heart failure.
- •Myocardial Infarction within 8 weeks of enrollment or unstable angina
研究组 & 干预措施
Therapy™ Cool Flex Ablation Catheter
干预措施: Therapy™ Cool Flex Ablation Catheter (Device)
结局指标
主要结局
Procedural parameters
时间窗: 6 months
* Ablation parameters (such as average power delivered , average tip temperature , average impedance ) * Lesion locations (such as PVI, Septal line, Mitral isthmus, CTI or any other lesion location) * Mapping techniques (Mapping system and catheter) * RF application time ( Calculated from the total number of RF application and duration of each RF application) * Ablation procedure time (Time from the first to the last RF application) * Total irrigation fluid administered during ablation procedure * Fluoroscopy time
Serious Adverse Events
时间窗: 6 months
All serious adverse events through six month follow-up
AF Recurrence
时间窗: 6 months
* Recurrence of AF through six months post last RF ablation procedure using Cool Flex catheter. A 24 hour Holter will be provided to the patients for six month follow-up visit in order to monitor AF episodes. An AF episode will be considered a recurrence only if it lasts for 30 seconds or more. * AF recurrences during the blanking period (defined below) will not be reported.
次要结局
未报告次要终点