Paroxysmal Atrial Fibrillation
Conditions
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.
Interventions
DEVICECardiac 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.
Sponsors
Biosense Webster, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Total Procedure Time | Total Duration of the Procedure |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Carto 3 Those subjects whose cases use the CARTO 3 EP Navigation System. | 46 |
| NAVX Those subjects whose cases use the NAVX(TM) EP Navigational System. | 47 |
| Total | 93 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 |
| Overall Study | Lack of Efficacy | 1 | 1 |
| Overall Study | Protocol Violation | 4 | 5 |
Baseline characteristics
| Characteristic | Carto 3 | NAVX | Total |
|---|---|---|---|
| Age, Continuous | 58 years | 57 years | 58 years |
| Sex: Female, Male Female | 14 Participants | 7 Participants | 21 Participants |
| Sex: Female, Male Male | 32 Participants | 40 Participants | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 46 | 0 / 47 |
| serious Total, serious adverse events | 1 / 46 | 3 / 47 |
Outcome results
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.
Time frame: Throughout the Total Duration of the Procedure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Carto 3 | Total Fluoroscopy Time | 31.0 minutes |
| NAVX | Total Fluoroscopy Time | 37.5 minutes |
Secondary
Total Procedure Time
Time frame: Total Duration of the Procedure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Carto 3 | Total Procedure Time | 160.5 minutes |
| NAVX | Total Procedure Time | 147.0 minutes |