Catheter Ablation Versus Antiarrhythmic Drugs for Outflow Tract Ventricular ARrhythmias

Overview

A randomized, parallel, open study comparing catheter ablation versus antiarrhythmic drugs for outflow tract ventricular arrhythmias

Study Type

  • Study Type: Interventional
  • Study Primary Completion Date: January 2014

Interventions

  • Drug: antiarrhythmic drugs (Flecainide or Propafenone or Sotalol)
  • Procedure: Catheter Ablation

Arms, Groups and Cohorts

  • Active Comparator: Antiarrhythmic drugs
    • Flecainide or Propafenone or Sotalol (oral, standard dosage)
  • Experimental: ABLATION
    • Catheter Ablation

Clinical Trial Outcome Measures

Primary Measures

  • SF-36 score
    • Time Frame: 6 months
    • Quality of life improvement according to SF-36 score variations

Participating in This Clinical Trial

Inclusion Criteria

1. presence of ventricular ectopic beats (VEB) with left-bundle-branch block morphology or right-bundle-branch block morphology and positive concordance throughout the chest leads, inferior axis and at least one of the following: 1. >2000 isolated VEB/24h 2. symptomatic monomorphic ventricular tachycardia 3. left ventricular disfunction supposed to be due to tachycardia-induced cardiomyopathy Exclusion Criteria:

1. known structural heart disease 2. pregnancy 3. life expectancy < 1 year

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ospedale San Donato
  • Provider of Information About this Clinical Study
    • Principal Investigator: Leonardo Bolognese, MD, Director – Ospedale San Donato

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