NCT01116557

Efficacy, Safety and Efficiency Study of CARTO® 3 System Guided THERMOCOOL® Catheter Ablation Versus Fluoroscopy Guided Ablation With the Pulmonary Vein Ablation Catheter® (PVAC®)

CARTO® 3 System-guided RF Ablation Using the THERMOCOOL® Catheter Versus Fluoroscopy-guided RF Ablation Using the Pulmonary Vein Ablation Catheter® (PVAC®) in Subjects With Paroxysmal Atrial Fibrillation: A Prospective, Multi-center, Randomized (2:1), Controlled, Two-arm, Unblinded Clinical Study

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Biosense Webster, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the efficacy, safety and efficiency of CARTO® 3 system guided THERMOCOOL® catheter ablation and fluoroscopy guided Pulmonary Vein Ablation Catheter® (PVAC®) guided ablation for the treatment of paroxysmal atrial fibrillation.

Detailed description

This study is a prospective, multi-center, randomized (2:1), controlled, two-arm, unblinded, clinical study, which will evaluate the efficacy, safety, and efficiency of CARTO® 3 System-guided RF ablation (using the THERMOCOOL® Catheter and LASSO® Circular Mapping Catheter) compared to fluoroscopy-guided RF ablation (using the PVAC®). Patients with symptomatic PAF who meet the inclusion criteria will be considered for study participation and may be enrolled if no exclusion criteria apply. Eligible subjects who signed the study informed consent form will be randomized into one of two treatment groups: * THERMOCOOL® Group: RF ablation to achieve PVI using the CARTO® 3 System, THERMOCOOL® Catheter and LASSO® Circular Mapping Catheter * PVAC® Group: RF ablation to achieve PVI using fluoroscopy and the PVAC®

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Radiofrequency Ablation procedure	Radiofrequency Ablation procedure Application of radiofrequency energy with the THERMOCOOL® catheter used in combination with the CARTO® 3 System and the LASSO® Circular Mapping Catheter to eliminate potentials arising from the pulmonary veins.
DEVICE	Radiofrequency Ablation procedure	Application of radiofrequency energy with the Pulmonary Vein Ablation Catheter® (PVAC®) to eliminate potentials arising from the pulmonary veins.

Timeline

• Start date: 2010-04-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2010-05-05
• Last updated: 2025-02-03