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

Primary Purpose

Heart Valve Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
HeartNavigator
EchoNav
Control-Group EN
Control-group HN
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Valve Diseases focused on measuring TAVI, MitraClip, image modality, echocardiography, angiography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital Zurich, Division of Cardiovascular SurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

HeartNavigator

Control

EchoNav

Conrol

Arm Description

Group with HeartNavigator-Software

Control-group without HeartNavigator-Software

Group with EchoNav-Software

Control-group without EchoNav-Software

Outcomes

Primary Outcome Measures

Radiation Dose (mSv) administered to each patient
At the end of the procedure the recorded radiation-dose is assessed.

Secondary Outcome Measures

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

Full Information

First Posted
December 10, 2012
Last Updated
June 18, 2013
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT01821651
Brief Title
Use of Standardized Diagnostic Imaging Data for Image Fusion in the Hybrid Operating Room
Official Title
Use of Standardized Diagnostic Imaging Data (Computertomography, Angiography, Echocardiography) for Image Fusion in the Hybrid Operating Room
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
January 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Valve Diseases
Keywords
TAVI, MitraClip, image modality, echocardiography, angiography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HeartNavigator
Arm Type
Experimental
Arm Description
Group with HeartNavigator-Software
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Control-group without HeartNavigator-Software
Arm Title
EchoNav
Arm Type
Experimental
Arm Description
Group with EchoNav-Software
Arm Title
Conrol
Arm Type
Active Comparator
Arm Description
Control-group without EchoNav-Software
Intervention Type
Device
Intervention Name(s)
HeartNavigator
Other Intervention Name(s)
HeartNavigator, procedure with software
Intervention Description
Procedure with software
Intervention Type
Device
Intervention Name(s)
EchoNav
Other Intervention Name(s)
EchoNav, procedure with software
Intervention Description
Procedure with software
Intervention Type
Other
Intervention Name(s)
Control-Group EN
Other Intervention Name(s)
Compare to EchoNav-group
Intervention Description
Procedure without software
Intervention Type
Other
Intervention Name(s)
Control-group HN
Other Intervention Name(s)
Compare to HeartNavigator-group
Intervention Description
Procedure without software
Primary Outcome Measure Information:
Title
Radiation Dose (mSv) administered to each patient
Description
At the end of the procedure the recorded radiation-dose is assessed.
Time Frame
Day of intervention (day 1)
Secondary Outcome Measure Information:
Title
Duration of the intervention (minutes)
Description
At the end of the procedure the skin-to-skin-time is assessed.
Time Frame
Day of intervention (day 1)
Title
Contrast agent dose (ml)
Description
At the end of the procedure the recorded contrast agent dose is assessed.
Time Frame
Day of intervention (day 1)
Title
Increased quality of care (EchoNav group)
Description
Usually 1 to 5 days after intervention
Time Frame
Discharge: 1 to 5 days after intervention
Title
Degree of Mitral Regurgitation (EchoNav group)
Description
Usually 1 to 5 days after intervention
Time Frame
Discharge: 1 to 5 days after intervention
Title
Postinterventional transvalvular gradient
Description
Catheter-based direct measurement
Time Frame
Up to 7 days after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Simon Sündermann, MD
Email
simon.suendermann@usz.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Volkmar Falk, Prof MD
Email
volkmar.falk@usz.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Volkmar Falk, Prof MD
Organizational Affiliation
University Hospital Zurich, Division of Cardiovascular Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich, Division of Cardiovascular Surgery
City
Zurich
State/Province
ZH
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting

12. IPD Sharing Statement

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

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