Clinical Evaluation of the CARTO™ XP EP Navigation System... | NCT00449085

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2007

Primary Completion Date

Jul 2012Estimated

Completion Date

Not provided

First Submitted Date

Mar 15, 2007

First Submission Date that Met QC Criteria

Mar 16, 2007

First Posted Date

Mar 19, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 31, 2025

Last Update Posted Date

Feb 3, 2025Actual

Name	Class
Royal Adelaide Hospital	OTHER
Melbourne Health	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Prashanthan Sanders, MBBS,PhD,FRCACP	Royal Adelaide Hospital	Study Director
Jonathan Kalman, MBBS,PhD,FRACP	Melbourne Health	Principal Investigator

Locations

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Name	Type	Description	Arm Group Labels	Other Names
Electrophysiology	Procedure
CARTO™ XP EP Navigation System V9	Device