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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Cardiac Arrhythmias

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Electrophysiology

Intervention Type PROCEDURE

CARTO™ XP EP Navigation System V9

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No