Atrial Fibrillation Clinical Trial
Official title:
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
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.
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®
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
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