CryoCath Freezor CryoAblation Catheter System (CRYOFACTS)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 8
- 主要终点
- Device or Procedure Related AV Block Persistent Through Discharge From Hospital.
研究概览
简要总结
The purpose of this post approval study of heart block is to gather additional information regarding how often patients develop heart block (atrioventricular block) after having standard ablation procedure using cryotherapy with the Freezor™ catheter.
详细描述
Due to the lack of enrollments for the trial. The FDA and Medtronic discussed the inclusion of data found from from published literature (external studies) to corroborate study endpoint. The FDA allowed this data and the study was closed.
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
- Treatment
- 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
- •Some inclusion criteria can only be established during the electrophysiologic study (EPS); thus there are two groups of inclusion criteria.
- •For inclusion in the study subjects must fulfill ALL of the following criteria:
- •Pre-EPS inclusion criteria:
- •Patients with a clinical history of AVNRT who are referred for ablation.
- •Patients willing to provide written informed consent.
- •Post-EPS inclusion criteria:
- •Patients with EPS-documented AVNRT
排除标准
- •ANY of the following is regarded as a criterion for excluding a subject from the study:
- •Patients with any pre-existing AV block.
- •Patients with known cryoglobulinemia
研究组 & 干预措施
Freezor Catheter for AVNRT
Subjects with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmia.
干预措施: Freezor® Cardiac Cryoablation Catheter CryoConsole System (Device)
External Data Supporting the Study
This arm was taken from pier reviewed published reports that include adult subjects ablated with the Freezor catheter for AVNRT.
干预措施: Freezor® Cardiac Cryoablation Catheter CryoConsole System (Device)
结局指标
主要结局
Device or Procedure Related AV Block Persistent Through Discharge From Hospital.
时间窗: After 250 subjects have been enrolled.
次要结局
- AV Block That Requires the Insertion of a Permanent Pacemaker: Defined as the Insertion of a Permanent Pacemaker, as Assessed During Defined Study Follow up.(After 250 subjects have been enrolled.)