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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Leonardo Bolognese, MD, Ospedale San Donato.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01780311
First Posted: January 31, 2013
Last Update Posted: January 31, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Leonardo Bolognese, MD, Ospedale San Donato
  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 Leonardo Bolognese, MD, Ospedale San Donato:

Primary Outcome Measures:
  • SF-36 score [ Time Frame: 6 months ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Leonardo Bolognese, MD, Director, Ospedale San Donato
ClinicalTrials.gov Identifier: NCT01780311     History of Changes
Other Study ID Numbers: Arezzo008
First Submitted: January 25, 2013
First Posted: January 31, 2013
Last Update Posted: January 31, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Ventricular
Ventricular Premature Complexes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cardiac Complexes, Premature
Anti-Arrhythmia Agents
Flecainide
Sotalol
Propafenone
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents