ACTRN12613000317796招募中1 期
Feasibility Study to assess the performance of IntellaTip MiFi™ XP Temperature Ablation Catheter System for the treatment of Subjects with Sustained or Recurrent Type I Atrial Flutter
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •* At least one (1) documented episode of type I atrial flutter preceding enrollment documented by 12-lead ECG, Holter monitor, rhythm strip, or trans telephonic monitor
- •* Subjects are clinically indicated for standard of care catheter ablation for type I atrial flutter
- •* Age 18 or above, or of legal age to give informed consent specific to state and national law
- •* Subjects or their legal representative are competent and willing to provide written informed consent to participate in the study and agree to (and are able to) comply with follow-up visits and evaluation
排除标准
- •* Any cardiac ablation within 90 days prior to enrollment
- •* Previous CTI ablation
- •* Cardiac surgery within 90 days prior to enrollment
- •* Myocardial infarction (MI) or cardiac revascularization (percutaneous coronary intervention) within 60 days prior to enrollment
- •* Current unstable angina
- •* Documented atrial or ventricular tumors, clots, thrombus, Deep Vein Thrombus (DVT)or have a known clotting disorder within 90 days prior to enrollment
- •* Implantation of permanent leads of an implantable device in or through the right atrium within 30 days prior to enrollment.
研究者
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