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

This study is currently recruiting participants.
Verified June 2013 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01821651
First received: December 10, 2012
Last updated: June 18, 2013
Last verified: June 2013

December 10, 2012
June 18, 2013
January 2012
January 2014   (final data collection date for primary outcome measure)
Radiation Dose (mSv) administered to each patient [ Time Frame: Day of intervention (day 1) ] [ Designated as safety issue: No ]
At the end of the procedure the recorded radiation-dose is assessed.
Same as current
Complete list of historical versions of study NCT01821651 on ClinicalTrials.gov Archive Site
  • Duration of the intervention (minutes) [ Time Frame: Day of intervention (day 1) ] [ Designated as safety issue: No ]
    At the end of the procedure the skin-to-skin-time is assessed.
  • Contrast agent dose (ml) [ Time Frame: Day of intervention (day 1) ] [ Designated as safety issue: No ]
    At the end of the procedure the recorded contrast agent dose is assessed.
  • Increased quality of care (EchoNav group) [ Time Frame: Discharge: 1 to 5 days after intervention ] [ Designated as safety issue: No ]
    Usually 1 to 5 days after intervention
  • Degree of Mitral Regurgitation (EchoNav group) [ Time Frame: Discharge: 1 to 5 days after intervention ] [ Designated as safety issue: No ]
    Usually 1 to 5 days after intervention
  • Postinterventional transvalvular gradient [ Time Frame: Up to 7 days after intervention ] [ Designated as safety issue: No ]
    Catheter-based direct measurement
Same as current
Not Provided
Not Provided
 
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

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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Heart Valve Diseases
  • Device: HeartNavigator
    Procedure with software
    Other Name: HeartNavigator, procedure with software
  • Device: EchoNav
    Procedure with software
    Other Name: EchoNav, procedure with software
  • Other: Control-Group EN
    Procedure without software
    Other Name: Compare to EchoNav-group
  • Other: Control-group HN
    Procedure without software
    Other Name: Compare to HeartNavigator-group
  • Experimental: HeartNavigator
    Group with HeartNavigator-Software
    Intervention: Device: HeartNavigator
  • Active Comparator: Control
    Control-group without HeartNavigator-Software
    Intervention: Other: Control-group HN
  • Experimental: EchoNav
    Group with EchoNav-Software
    Intervention: Device: EchoNav
  • Active Comparator: Conrol
    Control-group without EchoNav-Software
    Intervention: Other: Control-Group EN
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
140
January 2014
January 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Simon Sündermann, MD simon.suendermann@usz.ch
Contact: Volkmar Falk, Prof MD volkmar.falk@usz.ch
Switzerland
 
NCT01821651
HOR-1
Yes
University of Zurich
University of Zurich
Not Provided
Principal Investigator: Volkmar Falk, Prof MD University Hospital Zurich, Division of Cardiovascular Surgery
University of Zurich
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP