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

January 30, 2013 updated by: Leonardo Bolognese, MD, Ospedale San Donato
A randomized, parallel, open study comparing catheter ablation versus antiarrhythmic drugs for outflow tract ventricular arrhythmias

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • AR
      • Arezzo, AR, Italy, 52100
        • Recruiting
        • Cardiovascular Department, Ospedale S.Donato
        • Contact:
        • Principal Investigator:
          • Leonardo Bolognese, MD, FESC
        • Principal Investigator:
          • Pasquale Notarstefano, MD
        • Sub-Investigator:
          • Simone Grotti

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SF-36 score
Time Frame: 6 months
Quality of life improvement according to SF-36 score variations
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale San Donato

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

January 1, 2014

Study Registration Dates

First Submitted

January 25, 2013

First Submitted That Met QC Criteria

January 30, 2013

First Posted (Estimate)

January 31, 2013

Study Record Updates

Last Update Posted (Estimate)

January 31, 2013

Last Update Submitted That Met QC Criteria

January 30, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Arezzo008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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