VIVO in a Practical Clinical Experience
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 8
- 主要终点
- Measure the effectiveness of VIVO within different types of VA procedures
研究概览
简要总结
A multi-center, observational registry conducted in Europe and the UK to prospectively review VIVO in a clinical setting in 125 patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patients must at least 18 years of age Patients who have signed an IRB/EC approved patient informed consent and applicable patient privacy protection authorization per local law
- •Patients who have previously had contrast cardiac imaging or will have cardiac imaging ordered per standard of care
- •Patients will be selected without regard to gender.
排除标准
- •Patients that are unable to receive contrast cardiac imaging (MR or CT)
结局指标
主要结局
Measure the effectiveness of VIVO within different types of VA procedures
时间窗: 1 day
The primary effectiveness objective is to assess the types of procedures where VIVO is used to plan and/or guide the ablation procedure or to determine a diagnosis of arrhythmia. Primary Effectiveness endpoint: Summarize the types of procedures where VIVO was utilized in the procedure to include the number of VT vs PVC, whether VIVO improved procedural planning and acute procedural success measured as termination or reduction in arrhythmia.
Measure the safety by observing adverse events related to the device and procedure
时间窗: 1 day
Primary safety objective is to assess any adverse events related to the device and procedure. Primary Safety endpoint: Summarize the number of adverse events related to VIVO or procedure.
次要结局
- Effectiveness(12 months)