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Clinical Evaluation of the CARTO™ XP EP Navigation System v9 and Biosense Webster SOUNDSTAR 3D Diagnostic Ultrasound. A Feasibility Study

Primary Purpose

Cardiac Arrhythmias

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Electrophysiology
CARTO™ XP EP Navigation System V9
Sponsored by
Biosense Webster, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiac Arrhythmias

Eligibility Criteria

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

Inclusion Criteria:

  • Subjects undergoing any EPS study and or Ablation will be eligible for this study.

Age 18 years or older Signed Patient Informed Consent Form

Exclusion Criteria:

  • Patients with inadequate vascular access

Patients with any of the following criteria will be excluded:

  • Women who are pregnant

    • Age <18 years
    • Any Contraindication to the clinical procedure
    • Sepsis
  • Major coagulation abnormalities
  • Presence of any intracardiac thrombus
  • Unstable angina
  • Uncontrolled Heart failure
  • Deep Vein Thrombosis
  • Significant peripheral vascular disease

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    March 15, 2007
    Last Updated
    January 5, 2015
    Sponsor
    Biosense Webster, Inc.
    Collaborators
    Royal Adelaide Hospital, Melbourne Health
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00449085
    Brief Title
    Clinical Evaluation of the CARTO™ XP EP Navigation System v9 and Biosense Webster SOUNDSTAR 3D Diagnostic Ultrasound. A Feasibility Study
    Official Title
    Clinical Evaluation of the CARTO™ XP EP Navigation System v9 and Biosense Webster SOUNDSTAR 3D Diagnostic Ultrasound. A Feasibility Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    April 2007 (undefined)
    Primary Completion Date
    July 2012 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Biosense Webster, Inc.
    Collaborators
    Royal Adelaide Hospital, Melbourne Health

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Feasibility study to evaluate CARTO™ XP EP Navigation System V9 and SOUNDSTAR 3D Diagnostic Ultrasound Catheter.
    Detailed Description
    To construct geometric representation of the heart chambers using intracardiac ultrasound.The Carto™ XP Electrophysiology (EP) Navigation System v9 is intended to acquire real-time catheter based cardiac electrophysiogical maps.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiac Arrhythmias

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    Electrophysiology
    Intervention Type
    Device
    Intervention Name(s)
    CARTO™ XP EP Navigation System V9

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects undergoing any EPS study and or Ablation will be eligible for this study. Age 18 years or older Signed Patient Informed Consent Form Exclusion Criteria: Patients with inadequate vascular access Patients with any of the following criteria will be excluded: Women who are pregnant Age <18 years Any Contraindication to the clinical procedure Sepsis Major coagulation abnormalities Presence of any intracardiac thrombus Unstable angina Uncontrolled Heart failure Deep Vein Thrombosis Significant peripheral vascular disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Prashanthan Sanders, MBBS,PhD,FRCACP
    Organizational Affiliation
    Royal Adelaide Hospital
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Jonathan Kalman, MBBS,PhD,FRACP
    Organizational Affiliation
    Melbourne Health
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Evaluation of the CARTO™ XP EP Navigation System v9 and Biosense Webster SOUNDSTAR 3D Diagnostic Ultrasound. A Feasibility Study

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