Heart Valve Diseases Clinical Trial
Official title:
Use of Standardized Diagnostic Imaging Data (Computertomography, Angiography, Echocardiography) for Image Fusion in the Hybrid Operating Room
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).
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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