Trial Outcomes & Findings for Guided Radiofrequency Ablation Using the CARTO® 3 and NavX™ Systems for the Treatment of Paroxysmal Atrial Fibrillation (NCT NCT01036724)

Results Overview

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.

Recruitment status

TERMINATED

Target enrollment

107 participants

Primary outcome timeframe

Throughout the Total Duration of the Procedure

Results posted on

2017-09-27

Participant Flow

Participant milestones

Participant milestones
Measure	NAVX Those subjects whose cases use the NAVX(TM) EP Navigational System.	Carto 3 Those subjects whose cases use the CARTO 3 EP Navigation System.
Overall Study STARTED	55	52
Overall Study COMPLETED	47	46
Overall Study NOT COMPLETED	8	6

Reasons for withdrawal

Reasons for withdrawal
Measure	NAVX Those subjects whose cases use the NAVX(TM) EP Navigational System.	Carto 3 Those subjects whose cases use the CARTO 3 EP Navigation System.
Overall Study Adverse Event	2	1
Overall Study Lack of Efficacy	1	1
Overall Study Protocol Violation	5	4

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Carto 3 n=46 Participants Those subjects whose cases use the CARTO 3 EP Navigation System.	NAVX n=47 Participants Those subjects whose cases use the NAVX(TM) EP Navigational System.	Total n=93 Participants Total of all reporting groups
Age, Continuous	58 years n=5 Participants	57 years n=7 Participants	58 years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	7 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	40 Participants n=7 Participants	72 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Carto 3 n=46 Participants Those subjects whose cases use the CARTO 3 EP Navigation System.	NAVX n=47 Participants Those subjects whose cases use the NAVX(TM) EP Navigational System.
Total Fluoroscopy Time	31.0 minutes Interval 0.7 to 61.6	37.5 minutes Interval 4.3 to 76.0

SECONDARY outcome

Timeframe: Total Duration of the Procedure

Outcome measures

Outcome measures
Measure	Carto 3 n=46 Participants Those subjects whose cases use the CARTO 3 EP Navigation System.	NAVX n=47 Participants Those subjects whose cases use the NAVX(TM) EP Navigational System.
Total Procedure Time	160.5 minutes Interval 82.0 to 414.0	147.0 minutes Interval 86.0 to 343.0

Adverse Events

Carto 3

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

NAVX

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Carto 3 n=46 participants at risk Those subjects whose cases use the CARTO 3 EP Navigation System.	NAVX n=47 participants at risk Those subjects whose cases use the NAVX(TM) EP Navigational System.
Cardiac disorders Atrial Perforation	0.00% 0/46 • Throughout the Duration of the Procedure	4.3% 2/47 • Number of events 2 • Throughout the Duration of the Procedure
Cardiac disorders Cardiac Tamponade	2.2% 1/46 • Number of events 1 • Throughout the Duration of the Procedure	2.1% 1/47 • Number of events 1 • Throughout the Duration of the Procedure

Other adverse events

Adverse event data not reported

Additional Information

Dr. Tina Hunter, Consulting Statistician to Biosense Webster

CTI Clinical Trials and Consulting

Phone: 513-619-5541

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place