NCT01821651

Use of Standardized Diagnostic Imaging Data for Image Fusion in the Hybrid Operating Room

Use of Standardized Diagnostic Imaging Data (Computertomography, Angiography, Echocardiography) for Image Fusion in the Hybrid Operating Room

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Heart Valve Diseases

Interventions

Type	Name	Description
DEVICE	HeartNavigator	Procedure with software
DEVICE	EchoNav	Procedure with software
OTHER	Control-Group EN	Procedure without software
OTHER	Control-group HN	Procedure without software

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2013-04-01
• Last updated: 2013-06-19

Locations

1 site across 1 country: Switzerland