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

PHASE3CompletedINTERVENTIONAL
Enrollment

167

Participants

Timeline

Start Date

October 1, 2004

Primary Completion Date

October 1, 2007

Study Completion Date

March 1, 2011

Conditions
Heart DiseasesArrhythmiaAtrial Fibrillation
Interventions
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.

Trial Locations (17)

10025

St. Lukes Roosevelt Hospital, New York

14642

University of Rochester Medical Center, Rochester

19104

University of Pennsylvania, Philadelphia

20132

Hospital San Raffaele, Milan

21287

Johns Hopkins Hospital, Baltimore

22042

Inova Fairfax Hospital, Falls Church

29403

Medical University of South Carolina, Charleston

32803

Florida Hospital, Orlando

43210

Ohio State University Medical Center, Columbus

43241

Riverside Methodist Hospital, Columbus

60153

Loyola University Medical Center, Maywood

75093

The Heart Hospital Baylor Plano Baylor Research Institute, Plano

94904

Marin General Hospital, Greenbrae

01805

Lahey Clinic Medical Center, Burlington

04024-002

Hospital Sao Paulo, São Paulo

H1T-iC8

Montreal Heart Institute, Montreal

150 30

Na Homolce Hospital, Prague

All Listed Sponsors
lead

Biosense Webster, Inc.

INDUSTRY

NCT00116428 - NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation | Biotech Hunter | Biotech Hunter