NCT01716663

CARTO® 3 System and Real Time Intracardiac Ultrasound

CARTO® 3 System and Real Time Intracardiac Ultrasound for Ablation of Drug Refractory Recurrent Symptomatic Paroxysmal AF: Acute Procedural Outcomes Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 234 (actual)
• Sponsor: Biosense Webster, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a prospective, multicenter, non-randomized observational study of subjects 18 years and older undergoing RF ablation with drug refractory recurrent symptomatic paroxysmal Atrial Fibrillation (AF).

Detailed description

This study is purposed to measure "real world" acute procedural outcomes (procedural efficiency and acute safety) associated with use of the CARTO® 3 System and real time intracardiac ultrasound in a clinical setting in subjects with drug refractory recurrent symptomatic paroxysmal AF.

Conditions

• Atrial Fibrillation
• Paroxysmal AF

Interventions

Type	Name	Description
DEVICE	Catheter Ablation	NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2012-10-30
• Last updated: 2014-12-01
• Results posted: 2014-12-01

Locations

26 sites across 1 country: United States