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

Cardiac Arrhythmias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00449085
• Other study ID #: RAH061225
• Status: Withdrawn
• Phase: Phase 2
• First received: March 15, 2007
• Last updated: January 5, 2015
• Start date: April 2007

Study information

• Verified date: January 2015
• Source: Biosense Webster, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Government of South Australia, Centeral Northern Adelaide Health service; Australia:
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmias

Intervention

Procedure:
• Electrophysiology

Device:
• CARTO™ XP EP Navigation System V9

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Biosense Webster, Inc.	Melbourne Health, Royal Adelaide Hospital