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

Biosense Webster

Status: Terminated

Conditions: Paroxysmal Atrial Fibrillation

Treatments: Device: Cardiac Mapping

Study type: Observational

Funder types: Industry

Identifiers

NCT01036724

BWICO1

Details and patient eligibility

About

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.

Enrollment: 107 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

107 participants in 2 patient groups

Carto 3

Description:

Those subjects whose cases use the CARTO 3 EP Navigation System.

Treatment:

Device: Cardiac Mapping

NAVX

Description:

Those subjects whose cases use the NAVX(TM) EP Navigational System.

Treatment:

Device: Cardiac Mapping