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

Paroxysmal Atrial Fibrillation Clinical Trial

— CO1  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01036724
• Other study ID #: BWICO1
• Status: Terminated
• Phase: N/A
• First received: December 17, 2009
• Last updated: August 30, 2017
• Start date: November 1, 2009
• Est. completion date: August 25, 2010

Study information

• Verified date: August 2017
• Source: Biosense Webster, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 107
• Est. completion date: August 25, 2010
• Est. primary completion date: August 1, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

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.

Locations

Country	Name	City	State
Canada	QE II Health Sciences Center	Halifax	Nova Scotia
Canada	London Health Sciences	London	Ontario
Canada	Southlake Regional Healthcare Centre	Newmarket	Ontario
Canada	Laval Hopital	Quebec City	Quebec
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Vancouver Island Health Authority - Royal Jubilee Hospital	Victoria	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Biosense Webster, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Fluoroscopy Time	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	Total Procedure Time		Total Duration of the Procedure