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

NCT00116428 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2017-10-24

Study results available
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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

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.

Sponsors & Collaborators

  • Biosense Webster, Inc.

    lead INDUSTRY

Principal Investigators

  • David Wilber, MD · Loyola University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-01
Primary Completion
2007-10-01
Completion
2011-03-01

Countries

  • United States
  • Brazil
  • Canada
  • Czechia
  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00116428 on ClinicalTrials.gov