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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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 Intervention
Heart Valve Diseases
Device: HeartNavigator
Device: EchoNav
Other: Control-Group EN
Other: Control-group HN

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Use of Standardized Diagnostic Imaging Data (Computertomography, Angiography, Echocardiography) for Image Fusion in the Hybrid Operating Room

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 140
Study Start Date: January 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01821651     History of Changes
Other Study ID Numbers: HOR-1
Study First Received: December 10, 2012
Last Updated: June 18, 2013
Health Authority: Switzerland: Swissmedic

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

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

ClinicalTrials.gov processed this record on July 09, 2014