NCT00116428

NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 167 (actual)
• Sponsor: Biosense Webster, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial compares the safety and effectiveness of catheter ablation for PAF with antiarrhythmic drug therapy. The investigational catheter being studied is the NAVISTAR® THERMOCOOL® irrigated-tip catheter. At the time of this study, the NAVISTAR® THERMOCOOL® catheter was FDA-approved for commercial distribution in the U.S. for treating patients with Type I atrial flutter and drug refractory monomorphic ventricular tachycardia post myocardial infarction. The catheter was approved for use in Europe for endocardial ablation for treating cardiac arrhythmias.

Conditions

• Heart Diseases
• Arrhythmia
• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	NAVISTAR® THERMOCOOL® Catheter	The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
DRUG	Antiarrhythmic drug	Subjects randomized to the antiarrhythmic drug (control) arm will be prescribed to a not previously administered class I or class III antiarrhythmic drug that is currently approved in the U.S. for treating atrial fibrillation.

Timeline

• Start date: 2004-10-01
• Primary completion: 2007-10-01
• Completion: 2011-03-01
• First posted: 2005-06-30
• Last updated: 2017-10-24
• Results posted: 2013-03-14

Locations

17 sites across 5 countries: United States, Brazil, Canada, Czechia, Italy