Status:
WITHDRAWN
Clinical Evaluation of the CARTO™ XP EP Navigation System v9 and Biosense Webster SOUNDSTAR 3D Diagnostic Ultrasound. A Feasibility Study
Lead Sponsor:
Biosense Webster, Inc.
Collaborating Sponsors:
Royal Adelaide Hospital
Melbourne Health
Conditions:
Cardiac Arrhythmias
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 card...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00449085
Start Date
April 1 2007
Last Update
February 3 2025
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