CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 127 enrolled
Drug / intervention
Conventional Antiarrhythmic Drug Therapy +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00392054
NCT00392054Phase 3Completed
CompareCT.gov

First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Atrial Fibrillation Treatment: A Multi-center Randomized Trial

Population Health Research Institute·interventional·Posted Oct 25, 2006·Updated Jan 31, 2020

In Brief

A Phase 3 clinical trial evaluating Pulmonary Vein Isolation performed by Catheter Ablation and Conventional Antiarrhythmic Drug Therapy for Atrial Fibrillation. Completed, enrolled 127 participants across 16 sites in 5 countries.

Detailed Summary

The purpose of this study is to determine whether catheter-based pulmonary vein isolation is superior to antiarrhythmic drugs as first line therapy in patients with symptomatic paroxysmal recurrent atrial fibrillation not previously treated with therapeutic doses of antiarrhythmic drugs.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
CountriesCanada, Czechia, Germany, Italy, United States
CollaboratorsJohnson & Johnson

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 25, 2006
Enrollment StartAug 1, 2006
Primary CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 19.7 years ago

Interventions

Pulmonary Vein Isolation performed by Catheter Ablationprocedure

Ablation will be done to achieve entrance block into all pulmonary veins.

Conventional Antiarrhythmic Drug Therapydrug

Anti-Arrhythmic Drugs per ACC/AHA 2006 Guidelines for the Management of Patients with AF