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

This study has been terminated.
(Enrollment challenges)
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT01036724
First received: December 17, 2009
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

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 Intervention
Paroxysmal Atrial Fibrillation
Device: Cardiac Mapping

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Biosense Webster, Inc.:

Primary Outcome Measures:
  • Total Fluoroscopy Time [ Time Frame: Throughout the Total Duration of the Procedure ] [ Designated as safety issue: Yes ]
    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:
  • Total Procedure Time [ Time Frame: Total Duration of the Procedure ] [ Designated as safety issue: No ]

Enrollment: 107
Study Start Date: November 2009
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01036724

Locations
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

No publications provided

Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT01036724     History of Changes
Other Study ID Numbers: BWICO1
Study First Received: December 17, 2009
Results First Received: June 18, 2014
Last Updated: July 17, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 24, 2014