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

NCT01821651 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2013-06-19

No results posted yet for this study

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).

Conditions

  • Heart Valve Diseases

Interventions

DEVICE

HeartNavigator

Procedure with software

DEVICE

EchoNav

Procedure with software

OTHER

Control-Group EN

Procedure without software

OTHER

Control-group HN

Procedure without software

Sponsors & Collaborators

  • University of Zurich

    lead OTHER

Principal Investigators

  • Volkmar Falk, Prof MD · University Hospital Zurich, Division of Cardiovascular Surgery

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01821651 on ClinicalTrials.gov