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Clinical Trials/NCT01780311
NCT01780311
Unknown
Phase 4

Catheter Ablation Versus Antiarrhythmic Drugs for Outflow Tract Ventricular ARrhythmias

Ospedale San Donato1 site in 1 countryJanuary 2013

Overview

Phase
Phase 4
Intervention
antiarrhythmic drugs (Flecainide or Propafenone or Sotalol)
Conditions
Ventricular Tachycardia
Sponsor
Ospedale San Donato
Locations
1
Primary Endpoint
SF-36 score
Last Updated
13 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
January 2014
Last Updated
13 years ago
Study Type
Interventional
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Leonardo Bolognese, MD

Director

Ospedale San Donato

Eligibility Criteria

Inclusion Criteria

  • 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:
  • \>2000 isolated VEB/24h
  • symptomatic monomorphic ventricular tachycardia
  • left ventricular disfunction supposed to be due to tachycardia-induced cardiomyopathy

Exclusion Criteria

  • known structural heart disease
  • life expectancy \< 1 year

Arms & Interventions

Antiarrhythmic drugs

Flecainide or Propafenone or Sotalol (oral, standard dosage)

Intervention: antiarrhythmic drugs (Flecainide or Propafenone or Sotalol)

ABLATION

Catheter Ablation

Intervention: Catheter Ablation

Outcomes

Primary Outcomes

SF-36 score

Time Frame: 6 months

Quality of life improvement according to SF-36 score variations

Study Sites (1)

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