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

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ClinicalTrials.gov Identifier: NCT01036724
Recruitment Status : Terminated (Enrollment challenges)
First Posted : December 21, 2009
Results First Posted : July 21, 2014
Last Update Posted : September 27, 2017
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.

Study Description
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Brief 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.


Condition or disease Intervention/treatment
Paroxysmal Atrial Fibrillation Device: Cardiac Mapping

Study Design
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Study Type : Observational
Actual Enrollment : 107 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Comparative Study of Guided Radiofrequency Ablation Using the CARTO® 3 and NavX™ Systems for the Treatment of Paroxysmal Atrial Fibrillation
Actual Study Start Date : November 1, 2009
Actual Primary Completion Date : August 1, 2010
Actual Study Completion Date : August 25, 2010

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Total Procedure Time [ Time Frame: Total Duration of the Procedure ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects referred for Radiofrequency ablation treatment for paroxysmal atrial fibrillation.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01036724


Locations
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Canada, British Columbia
Vancouver Island Health Authority - Royal Jubilee Hospital
Victoria, British Columbia, Canada, V8R 1J8
Canada, Nova Scotia
QE II Health Sciences Center
Halifax, Nova Scotia, Canada, B3H 3Q7
Canada, Ontario
London Health Sciences
London, Ontario, Canada, N6A 5A5
Southlake Regional Healthcare Centre
Newmarket, Ontario, Canada, L3Y8C3
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
Laval Hopital
Quebec City, Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Biosense Webster, Inc.
More Information
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Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT01036724    
Other Study ID Numbers: BWICO1
First Posted: December 21, 2009    Key Record Dates
Results First Posted: July 21, 2014
Last Update Posted: September 27, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes