Cryterion Cardiac Cryoablation System CE Mark Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 4
- 主要终点
- Primary Safety Outcome: Percentage of Participants With Procedure Related Adverse Events OR Device Related Adverse Events OR Serious Adverse Device Effects
研究概览
简要总结
Multi-center, open label, prospective clinical study to establish the acute safety and performance of the Cryterion Cardiac Cryoablation System
详细描述
This is a single-arm, open-label clinical study using a cryoablation balloon device to isolate pulmonary veins during an atrial fibrillation ablation procedure. Cryo is a scientifically proven energy source used to create a thermal injury during endocardial ablation. The investigational device uses current technology with minor design modifications and will be studied to validate similarities in the safety and performance parameters compared to literature.
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
- 否
入选标准
- •Currently scheduled for a de novo ablation of atrial fibrillation (AF) defined as AF with self-terminating episodes lasting no longer than 7 continuous days (PAF)
排除标准
- •In the opinion of the Investigator, any known contraindication to an AF ablation, Transesophageal Echocardiogram (TEE). or anticoagulation
- •Any duration of continuous AF lasting longer than 7 days
- •History of previous left atrial ablation or surgical treatment for Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia (AF/AFL/AT)
- •More than four (4) electrical cardioversions in the year prior to enrollment excluding cardioversions performed within 24 hours of arrhythmia onset.
- •Significant structural heart disease or implanted cardiac devices
结局指标
主要结局
Primary Safety Outcome: Percentage of Participants With Procedure Related Adverse Events OR Device Related Adverse Events OR Serious Adverse Device Effects
时间窗: 12 months
Percentage of participants with procedure related adverse events OR device related adverse events OR Serious Adverse device effects including: Death, Myocardial Infarction, Cardiac perforation/pericardial tamponade, Cerebral Infarct or systemic embolism, Major bleeding requiring transfusion of blood products, Mitral or tricuspid valvular damage, phrenic nerve damage causing persistent diaphragmatic paralysis, Symptomatic pulmonary vein stenosis, atrio-esophageal fistula, Air embolism leading to life-threatening event, other serious adverse device effects (SADEs)
Acute Procedural Success
时间窗: Following the last cryo-application for each of the targeted veins, during the index procedure. Mean procedure time was 118 minutes.
Percentage of patients achieving pulmonary vein isolation defined as entrance and exit block for each of the targeted pulmonary veins following the last ablation application.
12 Month Treatment Success - Percentage of Subjects Free From Arrhythmias at 12 Months
时间窗: 12 months
A treatment failure is defined as a subject being an acute procedural failure, having more than one repeat procedure during the 90-day blanking period or having a documented, symptomatic episode(s) of atrial fibrillation or atrial tachycardia, between 91 and 365 days post index procedure. Occurrence or recurrence of a right atrial arrhythmia is not considered a treatment failure post the 90-day blanking period
次要结局
- Percentage of Subjects With Isolation Immediately Post Ablation and With Reconnection During the Entrance/Exit Block Testing(30 minutes)
- Secondary Safety Outcome: Number of Procedure-related or Device Related Adverse Events.(12 months)