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

Not Applicable

• Conditions: Heart Valve Diseases
• Interventions: Device: HeartNavigator; Other: Control-group HN; Device: EchoNav; Other: Control-Group EN

• Registration Number: NCT01821651
• Lead Sponsor: University of Zurich

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-12-10
• Study First Submitted QC: 2013-03-29
• Study First Posted: 2013-04-01
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-18
• Last Update Posted: 2013-06-19
• Primary Completion: 2014-01
• Study Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HeartNavigator	HeartNavigator	Group with HeartNavigator-Software
Control	Control-group HN	Control-group without HeartNavigator-Software
EchoNav	EchoNav	Group with EchoNav-Software
Conrol	Control-Group EN	Control-group without EchoNav-Software

Primary Outcome Measures

Name	Time	Method
Radiation Dose (mSv) administered to each patient	Day of intervention (day 1)	At the end of the procedure the recorded radiation-dose is assessed.

Secondary Outcome Measures

Name	Time	Method
Duration of the intervention (minutes)	Day of intervention (day 1)	At the end of the procedure the skin-to-skin-time is assessed.
Contrast agent dose (ml)	Day of intervention (day 1)	At the end of the procedure the recorded contrast agent dose is assessed.
Increased quality of care (EchoNav group)	Discharge: 1 to 5 days after intervention	Usually 1 to 5 days after intervention
Degree of Mitral Regurgitation (EchoNav group)	Discharge: 1 to 5 days after intervention	Usually 1 to 5 days after intervention
Postinterventional transvalvular gradient	Up to 7 days after intervention	Catheter-based direct measurement

Trial Locations

Locations (1)

University Hospital Zurich, Division of Cardiovascular Surgery; 🇨🇭 Zurich, ZH, Switzerland