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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014