drugset / Trial / NCT00340314

A Trial of Circumferential Pulmonary Vein Ablation (CPVA) Versus Antiarrhythmic Drug Therapy in for Paroxysmal Atrial Fibrillation (AF)

NCT00340314 ↗

Phase 4 Completed 198 enrolled IRCCS San Raffaele
RandomizedParallel-groupOpen-labelTreatment

Summary

Background: Circumferential pulmonary vein ablation (CPVA) has been safely and effectively performed for treating paroxysmal atrial fibrillation (PAF); however, its safety and efficacy, as compared with those of antiarrhythmic drug therapy (ADT), have never been formally assessed in a randomized controlled trial. The Purpose of this study was to evaluate CPVA versus ADT in patients with PAF in a randomized controlled trial.

Timeline

Start
2005-01
Primary completion
—
Completion
2006-05

Outcome

Met primary endpoint

paper 72.7% of patients in the ablation arm and 56.5% of those initially randomly assigned to AADs were free of recurrent atrial fibrillation/atrial tachycardia (P=0.017). PMID 21946315 ↗

paper With follow-up extended to 4 years after randomly assigned, ablation remains superior to antiarrhythmic drug in these patients with paroxysmal atrial fibrillation. PMID 21946315 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Amiodarone Small molecule — —
Subject flecainide Small molecule — —
Subject sotalol Small molecule — —

Indications