NCT00449085

Brief Summary

Feasibility study to evaluate CARTO™ XP EP Navigation System V9 and SOUNDSTAR 3D Diagnostic Ultrasound Catheter.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 19, 2007

Completed
13 days until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Last Updated

February 3, 2025

Status Verified

January 1, 2025

Enrollment Period

5.3 years

First QC Date

March 15, 2007

Last Update Submit

January 31, 2025

Conditions

Cardiac Arrhythmias

Interventions

ElectrophysiologyPROCEDURE
CARTO™ XP EP Navigation System V9DEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects undergoing any EPS study and or Ablation will be eligible for this study.
  • Age 18 years or older Signed Patient Informed Consent Form

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Prashanthan Sanders, MBBS,PhD,FRCACP

    Royal Adelaide Hospital

    STUDY DIRECTOR

  • Jonathan Kalman, MBBS,PhD,FRACP

    Melbourne Health

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2007

First Posted

March 19, 2007

Study Start

April 1, 2007

Primary Completion

July 1, 2012

Last Updated

February 3, 2025

Record last verified: 2025-01