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

Primary Purpose

Ventricular Tachycardia, Ventricular Premature Complexes

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
antiarrhythmic drugs (Flecainide or Propafenone or Sotalol)
Catheter Ablation
Sponsored by
Ospedale San Donato
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Ventricular Tachycardia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cardiovascular Department, Ospedale S.DonatoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Antiarrhythmic drugs

ABLATION

Arm Description

Flecainide or Propafenone or Sotalol (oral, standard dosage)

Catheter Ablation

Outcomes

Primary Outcome Measures

SF-36 score
Quality of life improvement according to SF-36 score variations

Secondary Outcome Measures

Full Information

First Posted
January 25, 2013
Last Updated
January 30, 2013
Sponsor
Ospedale San Donato
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1. Study Identification

Unique Protocol Identification Number
NCT01780311
Brief Title
Catheter Ablation Versus Antiarrhythmic Drugs for Outflow Tract Ventricular ARrhythmias
Acronym
AVATAR
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale San Donato

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia, Ventricular Premature Complexes

7. Study Design

Study Phase
Phase 4

8. Arms, Groups, and Interventions

Arm Title
Antiarrhythmic drugs
Arm Type
Active Comparator
Arm Description
Flecainide or Propafenone or Sotalol (oral, standard dosage)
Arm Title
ABLATION
Arm Type
Experimental
Arm Description
Catheter Ablation
Intervention Type
Drug
Intervention Name(s)
antiarrhythmic drugs (Flecainide or Propafenone or Sotalol)
Intervention Type
Procedure
Intervention Name(s)
Catheter Ablation
Primary Outcome Measure Information:
Title
SF-36 score
Description
Quality of life improvement according to SF-36 score variations
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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: >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 pregnancy life expectancy < 1 year
Facility Information:
Facility Name
Cardiovascular Department, Ospedale S.Donato
City
Arezzo
State/Province
AR
ZIP/Postal Code
52100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pasquale Notarstefano, MD
Email
notarstefano2001@yahoo.it
First Name & Middle Initial & Last Name & Degree
Leonardo Bolognese, MD, FESC
First Name & Middle Initial & Last Name & Degree
Pasquale Notarstefano, MD
First Name & Middle Initial & Last Name & Degree
Simone Grotti

12. IPD Sharing Statement

Learn more about this trial

Catheter Ablation Versus Antiarrhythmic Drugs for Outflow Tract Ventricular ARrhythmias

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