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Status:

UNKNOWN

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

Lead Sponsor:

University of Zurich

Conditions:

Heart Valve Diseases

Eligibility:

All Genders

18+ years

Phase:

NA

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...

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...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    January 1 2012

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    January 1 2014

    Estimated Enrollment :

    140 Patients enrolled

    Trial Details

    Trial ID

    NCT01821651

    Start Date

    January 1 2012

    End Date

    January 1 2014

    Last Update

    June 19 2013

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    University Hospital Zurich, Division of Cardiovascular Surgery

    Zurich, Canton of Zurich, Switzerland, 8091