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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00449085

Enrollment

Registered

2007-03-19

Start date

2007-04-30

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrhythmias

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.

Interventions

PROCEDUREElectrophysiology

DEVICECARTO™ XP EP Navigation System V9

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026