CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 167 enrolled
Drug / intervention
Antiarrhythmic drug +1 moredrug
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Symptomatic paroxysmal atrial fibrillation with ≥3 documented AF episodes in prior 6 months
  • ✓Failed at least one prior antiarrhythmic drug (Class I, III, or AV nodal blocking agents) due to recurrent AF or intolerable side effects
  • ✓Age ≥18 years
  • ✓Able and willing to comply with all study requirements
Key exclusion· 19
  • ✕Previous atrial fibrillation ablation
  • ✕Amiodarone therapy within prior 6 months
  • ✕AF episodes lasting >30 days terminated by cardioversion
  • ✕Any valvular cardiac surgery

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00116428
NCT00116428Phase 3Completed
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NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation

Biosense Webster, Inc.·interventional·Posted Jun 30, 2005·Updated Oct 24, 2017

In Brief

A Phase 3 clinical trial evaluating NAVISTAR® THERMOCOOL® Catheter and Antiarrhythmic drug for Heart Diseases and 2 related conditions. Completed, enrolled 167 participants across 17 sites in 5 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Diseases, Arrhythmia, Atrial Fibrillation
CountriesBrazil, Canada, Czechia, Italy, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 30, 2005
Enrollment StartOct 1, 2004
Primary CompletionOct 1, 2007
Study CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 21.0 years ago

Interventions

NAVISTAR® THERMOCOOL® Catheterdevice

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.

Antiarrhythmic drugdrug

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.