VIVO™ Accuracy Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 3
- 主要终点
- Accuracy of correctly identifying PVC or VT origin
研究概览
简要总结
A multi-center study designed to assess the accuracy of VIVO™ in determining the location of a PVC/VT foci in comparison to an electroanatomical mapping system.
详细描述
The VIVO accuracy study will assess the accuracy of locating a PVC/VT foci by pacing known anatomical locations and comparing the VIVO outcome to that of the Carto system (Biosense-Webster).
研究设计
- 研究类型
- 干预性
- 分配方式
- 不适用
- 干预模型
- 单组
- 主要目的
- 诊断
- 盲法
- 开放（无盲法）
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
- Subjects who are at least 18 years or older
- Subjects who are scheduled for PVC/VT ablation procedure with structurally normal hearts and less than 10% scar.
- Subjects who have signed an IRB/EC approved Informed Consent Form and applicable subject privacy protection authorization per local law
- Subjects will be selected without regard to gender or age (unless precluded by local regulatory requirements)
排除标准
- Subjects who are contraindicated for CT or MRI (must be able to get one)
- Subject whose MRI or CT scan does not comply with the requirements of this protocol
- Subjects who are contraindicated for an electrophysiology procedure and/or fluoroscopy:
- INR > 3
- Active infection
- Pregnancy: Females of childbearing potential with a positive pregnancy test.
- Existing mechanical heart valve
研究组 & 干预措施
Single Arm
All patients will undergo standard of care ablation procedures. VIVO™ results will be compared to that of standard of care results, but will not be used in diagnosis or treatment.
干预措施: VIVO™ (Device)
结局指标
主要结局
Accuracy of correctly identifying PVC or VT origin
时间窗: 1 Day
Determine the accuracy of VIVO in identifying a PVC/VT to the left or right ventricle or the septum. The origin, identified by VIVO, will be compared to the Carto system and the successful ablation location.
次要结局
- Accuracy of correctly identifying known pacing sites(1 Day)
- Number of adverse events(1 Day)
研究者
研究点 (3)
标识符
- NCT 编号
- NCT03340142
- 其他研究编号
- 94-9001-004
日期
- 首次提交
- (8年前)
- 首次发布
- (8年前)
- 主要完成日期
- (8年前)
- 研究完成日期
- (7年前)
- 最近核实
- (7年前)
- 最近更新
- (7年前)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 是
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否