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

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ClinicalTrials.gov Identifier: NCT01821651
Recruitment Status : Unknown
Verified June 2013 by University of Zurich.
Recruitment status was:  Recruiting
First Posted : April 1, 2013
Last Update Posted : June 19, 2013
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Heart Valve Diseases Device: HeartNavigator Device: EchoNav Other: Control-Group EN Other: Control-group HN Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Use of Standardized Diagnostic Imaging Data (Computertomography, Angiography, Echocardiography) for Image Fusion in the Hybrid Operating Room
Study Start Date : January 2012
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Contrast agent dose (ml) [ Time Frame: Day of intervention (day 1) ]
    At the end of the procedure the recorded contrast agent dose is assessed.

  3. Increased quality of care (EchoNav group) [ Time Frame: Discharge: 1 to 5 days after intervention ]
    Usually 1 to 5 days after intervention

  4. Degree of Mitral Regurgitation (EchoNav group) [ Time Frame: Discharge: 1 to 5 days after intervention ]
    Usually 1 to 5 days after intervention

  5. Postinterventional transvalvular gradient [ Time Frame: Up to 7 days after intervention ]
    Catheter-based direct measurement



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01821651


Contacts
Contact: Simon Sündermann, MD simon.suendermann@usz.ch
Contact: Volkmar Falk, Prof MD volkmar.falk@usz.ch

Locations
Switzerland
University Hospital Zurich, Division of Cardiovascular Surgery Recruiting
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Volkmar Falk, Prof MD University Hospital Zurich, Division of Cardiovascular Surgery

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01821651     History of Changes
Other Study ID Numbers: HOR-1
First Posted: April 1, 2013    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: June 2013

Keywords provided by University of Zurich:
TAVI
MitraClip
image modality
echocardiography
angiography

Additional relevant MeSH terms:
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases