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

Phase 2

Withdrawn

• Conditions: Cardiac Arrhythmias

• Registration Number: NCT00449085
• Lead Sponsor: Biosense Webster, Inc.

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.

Study Timeline

• Study First Submitted: 2007-03-15
• Study First Submitted QC: 2007-03-16
• Study First Posted: 2007-03-19
• Study Start: 2007-04
• Primary Completion: 2012-07
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP