Use of Standardized Diagnostic Imaging Data (Computertomography, Angiography, Echocardiography) for Image Fusion in the Hybrid Operating Room
试验速览
- 阶段
- 不适用
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Radiation Dose (mSv) administered to each patient
研究概览
简要总结
Objectives:
Goal of the study is to investigate the potential benefit that transcatheter interventions such as Transcatheter Aortic Valve Implantation (TAVI), MitraClip, Left Atrial Appendage Closure and catheter Ablation can gain from multimodal image fusion techniques as they are available in the Hybrid suite.
Both the HeartNavigator and the EchoNav aim at decreasing the exposure to radiation and contrast agent, to shorten the operation time (efficacy), and to increase the quality of care (safety).
This pilot study aims at observing these aims on a small patient population and a control group.
Number of Subjects:
140 patients total in 6 groups:
- MitraClip, Left Atrial Appendage Closure or catheter Ablation with EchoNav (20, lead-in stage).
- MitraClip randomized with EchoNav (25), MitraClip randomized without EchoNav (25).
- TAVI with HeartNavigator lead in (10)
- TAVI randomized with HeartNavigator (30), TAVI randomized without HeartNavigator (30).
详细描述
Medical Device:
HeartNavigator: System for preoperative image-based assessment of aortic root geometry, planning of transcatheter aortic valve implantation, and intraoperative C-Arm control.
EchoNav: System for intraoperative registration of 3D Echo images with X-ray fluoroscopy images.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Radiation Dose (mSv) administered to each patient
时间窗: Day of intervention (day 1)
At the end of the procedure the recorded radiation-dose is assessed.
次要结局
- Duration of the intervention (minutes)(Day of intervention (day 1))
- Contrast agent dose (ml)(Day of intervention (day 1))
- Increased quality of care (EchoNav group)(Discharge: 1 to 5 days after intervention)
- Degree of Mitral Regurgitation (EchoNav group)(Discharge: 1 to 5 days after intervention)
- Postinterventional transvalvular gradient(Up to 7 days after intervention)