Catheter Ablation Versus Antiarrhythmic Drugs for Outflow Tract Ventricular ARrhythmias (AVATAR)

This study is currently recruiting participants.
Verified January 2013 by Ospedale San Donato
Sponsor:
Information provided by (Responsible Party):
Leonardo Bolognese, MD, Ospedale San Donato
ClinicalTrials.gov Identifier:
NCT01780311
First received: January 25, 2013
Last updated: January 30, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention Phase
Ventricular Tachycardia
Ventricular Premature Complexes
Drug: antiarrhythmic drugs (Flecainide or Propafenone or Sotalol)
Procedure: Catheter Ablation
Phase 4

Study Type: Interventional

Resource links provided by NLM:


Further study details as provided by Ospedale San Donato:

Primary Outcome Measures:
  • SF-36 score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Quality of life improvement according to SF-36 score variations


Study Start Date: January 2013
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Antiarrhythmic drugs
Flecainide or Propafenone or Sotalol (oral, standard dosage)
Drug: antiarrhythmic drugs (Flecainide or Propafenone or Sotalol)
Experimental: ABLATION
Catheter Ablation
Procedure: Catheter Ablation

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01780311

Locations
Italy
Cardiovascular Department, Ospedale S.Donato Recruiting
Arezzo, AR, Italy, 52100
Contact: Pasquale Notarstefano, MD       notarstefano2001@yahoo.it   
Principal Investigator: Leonardo Bolognese, MD, FESC         
Principal Investigator: Pasquale Notarstefano, MD         
Sub-Investigator: Simone Grotti         
Sponsors and Collaborators
Ospedale San Donato
  More Information

No publications provided

Responsible Party: Leonardo Bolognese, MD, Director, Ospedale San Donato
ClinicalTrials.gov Identifier: NCT01780311     History of Changes
Other Study ID Numbers: Arezzo008
Study First Received: January 25, 2013
Last Updated: January 30, 2013
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Ventricular
Ventricular Premature Complexes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cardiac Complexes, Premature
Anti-Arrhythmia Agents
Propafenone
Flecainide
Sotalol
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014