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Guided Radiofrequency Ablation Using the CARTO® 3 and NavX™ Systems for the Treatment of Paroxysmal Atrial Fibrillation

NCT01036724 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 107

Last updated 2017-09-27

Study results available
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Summary

The purpose of this study is to determine the change in median radiation exposure time and median procedure time following guided radiofrequency (RF) ablation among subjects undergoing treatment for paroxysmal atrial fibrillation with either the CARTO® 3 or the NavX(TM) System.

It is hypothesized that described features will reduce the median radiation exposure during the CARTO® 3 system-guided procedures compared to the NavX(TM) system-guided procedures.

Conditions

  • Paroxysmal Atrial Fibrillation

Interventions

DEVICE

Cardiac Mapping

Generating a cardiac map using the study device (CARTO 3) compared to the control device (NAVX\[TM\]) and measuring the amount of radiation exposure duration for each.

Sponsors & Collaborators

  • Biosense Webster, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-01
Primary Completion
2010-08-01
Completion
2010-08-25

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01036724 on ClinicalTrials.gov