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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