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

NCT ID: NCT01036724

Last Updated: 2017-09-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

107 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-01

Study Completion Date

2010-08-25

Brief Summary

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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.

Detailed Description

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Conditions

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Paroxysmal Atrial Fibrillation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Carto 3

Those subjects whose cases use the CARTO 3 EP Navigation System.

Cardiac Mapping

Intervention Type DEVICE

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.

NAVX

Those subjects whose cases use the NAVX(TM) EP Navigational System.

Cardiac Mapping

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All patients referred for a first radiofrequency ablation procedure for treatment of paroxysmal atrial fibrillation (AF episodes that last less than 30 days and are not terminated via cardioversion) and who are considered eligible for treatment by the physician.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biosense Webster, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Vancouver Island Health Authority - Royal Jubilee Hospital

Victoria, British Columbia, Canada

Site Status

QE II Health Sciences Center

Halifax, Nova Scotia, Canada

Site Status

London Health Sciences

London, Ontario, Canada

Site Status

Southlake Regional Healthcare Centre

Newmarket, Ontario, Canada

Site Status

St. Michael's Hospital

Toronto, Ontario, Canada

Site Status

Laval Hopital

Québec, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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BWICO1

Identifier Type: -

Identifier Source: org_study_id