Phase Ⅳ Study of CARTO 3D Mapping System vs Conventional Method in AF & VT
试验速览
- 阶段
- 4 期
- 入组人数
- 160
- 试验地点
- 5
- 主要终点
- Procedural duration
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of electroanatomic imaging compared to conventional method in patients with VT.
详细描述
To evaluate the efficacy and safety of electroanatomic imaging (CARTO) compared to conventional fluoroscopically guided activation mapping (Conventional) method in patients with Atrial Fibrillation and Substrate-dependent Ventricular Tachycardia To evaluate cost-effectiveness of CARTO 3D image system compared to conventional method in the same study subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with AF or substrate-dependent VT
排除标准
- •administering with anticoagulants
研究组 & 干预措施
Angiography
Conventional fluoroscopically guided activation mapping
干预措施: Angiography (Device)
CARTO 3D
CARTO (3D Electroanatomic imaging)
干预措施: CARTO 3D (Device)
结局指标
主要结局
Procedural duration
时间窗: 24weeks
Time from after puncture to catheter remover
Fluoroscopic time
时间窗: 24weeks
Total duration of procedure using fluoroscopy on , in minute
次要结局
- Survival Rate(24weeks)
- Cost Effectiveness(24weeks)
- Morphology of ablation(24weeks)
- Complications(24weeks)
- Ablation time(24weeks)
- Procedural Success(24weeks)
- Clinical Success(24weeks)
- Radiation dose(24weeks)