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

December 17, 2009
July 17, 2014
November 2009
August 2010   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT01036724 on ClinicalTrials.gov Archive Site
Total Procedure Time [ Time Frame: Total Duration of the Procedure ] [ Designated as safety issue: No ]
Not Provided
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Guided Radiofrequency Ablation Using the CARTO® 3 and NavX™ Systems for the Treatment of Paroxysmal Atrial Fibrillation
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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Subjects referred for Radiofrequency ablation treatment for paroxysmal atrial fibrillation.

Paroxysmal Atrial Fibrillation
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.
  • Carto 3
    Those subjects whose cases use the CARTO 3 EP Navigation System.
    Intervention: Device: Cardiac Mapping
  • NAVX
    Those subjects whose cases use the NAVX(TM) EP Navigational System.
    Intervention: Device: Cardiac Mapping
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
107
Not Provided
August 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01036724
BWICO1
No
Biosense Webster, Inc.
Biosense Webster, Inc.
Not Provided
Not Provided
Biosense Webster, Inc.
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP