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

Terminated

• Conditions: Paroxysmal Atrial Fibrillation
• Interventions: Device: Cardiac Mapping

• Registration Number: NCT01036724
• Lead Sponsor: Biosense Webster, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-01
• Study First Submitted: 2009-12-17
• Study First Submitted QC: 2009-12-18
• Study First Posted: 2009-12-21
• Primary Completion: 2010-08-01
• Study Completion: 2010-08-25
• Results First Submitted: 2014-06-18
• Results First Submitted QC: 2014-07-17
• Results First Posted: 2014-07-21
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-30
• Last Update Posted: 2017-09-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 107

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Carto 3	Cardiac Mapping	Those subjects whose cases use the CARTO 3 EP Navigation System.
NAVX	Cardiac Mapping	Those subjects whose cases use the NAVX(TM) EP Navigational System.

Primary Outcome Measures

Name	Time	Method
Total Fluoroscopy Time	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

Name	Time	Method
Total Procedure Time	Total Duration of the Procedure

Trial Locations

Locations (6)

Vancouver Island Health Authority - Royal Jubilee Hospital; 🇨🇦 Victoria, British Columbia, Canada

London Health Sciences; 🇨🇦 London, Ontario, Canada

Southlake Regional Healthcare Centre; 🇨🇦 Newmarket, Ontario, Canada

Laval Hopital; 🇨🇦 Quebec City, Quebec, Canada

QE II Health Sciences Center; 🇨🇦 Halifax, Nova Scotia, Canada

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada