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

January 5, 2015 updated by: Biosense Webster, Inc.
Feasibility study to evaluate CARTO™ XP EP Navigation System V9 and SOUNDSTAR 3D Diagnostic Ultrasound Catheter.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biosense Webster, Inc.

Collaborators

Melbourne Health
Royal Adelaide Hospital

Investigators

  • Study Director: Prashanthan Sanders, MBBS,PhD,FRCACP, Royal Adelaide Hospital
  • Principal Investigator: Jonathan Kalman, MBBS,PhD,FRACP, Melbourne Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Anticipated)

July 1, 2012

Study Registration Dates

First Submitted

March 15, 2007

First Submitted That Met QC Criteria

March 16, 2007

First Posted (Estimate)

March 19, 2007

Study Record Updates

Last Update Posted (Estimate)

January 6, 2015

Last Update Submitted That Met QC Criteria

January 5, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAH061225

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiac Arrhythmias

Clinical Trials on Electrophysiology

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe