Guided Radiofrequency Ablation Using the CARTO® 3 and NavX™ Systems for the Treatment of Paroxysmal Atrial Fibrillation (CO1)

August 30, 2017 updated by: Biosense Webster, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

107

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Victoria, British Columbia, Canada, V8R 1J8
        • Vancouver Island Health Authority - Royal Jubilee Hospital
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3Q7
        • QE II Health Sciences Center
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences
      • Newmarket, Ontario, Canada, L3Y8C3
        • Southlake Regional Healthcare Centre
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital
    • Quebec
      • Quebec City, Quebec, Canada, G1V 4G5
        • Laval Hopital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects referred for Radiofrequency ablation treatment for paroxysmal atrial fibrillation.

Description

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.

Exclusion Criteria:

  • There are no study specific exclusion criteria for this observational study. The exclusion criteria will be conditions that, in the physicians opinion, preclude an RF ablation procedure because the procedure risks outweigh any potential benefits for the subject.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Carto 3
Those subjects whose cases use the CARTO 3 EP Navigation System.
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.
NAVX
Those subjects whose cases use the NAVX(TM) EP Navigational System.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Fluoroscopy Time
Time Frame: Throughout the Total Duration of the Procedure
The primary outcome measure of this study is to measure and compare total fluoroscopy exposure time (minutes) at the conclusion of radiofrequency ablation for the treatment of paroxysmal atrial fibrillation, when guided by the CARTO® 3 or the NavX(TM) System in similar procedures.
Throughout the Total Duration of the Procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Total Procedure Time
Time Frame: Total Duration of the Procedure
Total Duration of the Procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biosense Webster, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2009

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 25, 2010

Study Registration Dates

First Submitted

December 17, 2009

First Submitted That Met QC Criteria

December 18, 2009

First Posted (Estimate)

December 21, 2009

Study Record Updates

Last Update Posted (Actual)

September 27, 2017

Last Update Submitted That Met QC Criteria

August 30, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BWICO1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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