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

June 18, 2013 updated by: University of Zurich

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
    • ZH
      • Zurich, ZH, Switzerland, 8091
        • Recruiting
        • University Hospital Zurich, Division of Cardiovascular Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Male and female patients over 18 years of age.
  • Ability and willingness to give informed consent.
  • Indication for TAVI, MitraClip, catheter ablation or percutaneous closure of the left atrial appendage procedure performed in the hybrid OR suite.
  • Recent good quality CTA (TAVI patients only, no CTA needed for EchoNav).

Exclusion criteria:

  • Contraindications on ethical grounds,
  • Women who are pregnant or breast feeding,
  • Emergency cases,
  • Contraindication or known hypersensitivity to contrast media which is unresponsive to pretreatment with steroids and antihistamines,
  • Known renal insufficiency (GFR < 50 ml/min) and patient is not on chronic hemodialysis (TAVI patients only, no contrast agent is necessary during MitraClip and transseptal puncture),
  • Contraindications for transesophageal Echo (EchoNav patients only, TAVI is possible without TEE and TEE is not needed for the HeartNavigator),
  • Known or suspected drug or alcohol abuse,
  • Enrollment into a clinical trial within last 4 weeks if overlapping enrolment is not explicitly approved by ethics committee for the two trials,
  • Patient is unable or unwilling to cooperate with the study protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HeartNavigator
Group with HeartNavigator-Software
Device: HeartNavigator
Procedure with software
Other Names:
  • HeartNavigator, procedure with software
Active Comparator: Control
Control-group without HeartNavigator-Software
Other: Control-group HN
Procedure without software
Other Names:
  • Compare to HeartNavigator-group
Experimental: EchoNav
Group with EchoNav-Software
Device: EchoNav
Procedure with software
Other Names:
  • EchoNav, procedure with software
Active Comparator: Conrol
Control-group without EchoNav-Software
Other: Control-Group EN
Procedure without software
Other Names:
  • Compare to EchoNav-group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiation Dose (mSv) administered to each patient
Time Frame: Day of intervention (day 1)
At the end of the procedure the recorded radiation-dose is assessed.
Day of intervention (day 1)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Volkmar Falk, Prof MD, University Hospital Zurich, Division of Cardiovascular Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

January 1, 2014

Study Completion (Anticipated)

January 1, 2014

Study Registration Dates

First Submitted

December 10, 2012

First Submitted That Met QC Criteria

March 29, 2013

First Posted (Estimate)

April 1, 2013

Study Record Updates

Last Update Posted (Estimate)

June 19, 2013

Last Update Submitted That Met QC Criteria

June 18, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOR-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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