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
About this trial
This is an interventional trial for Ventricular Tachycardia
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
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
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
We'll reach out to this number within 24 hrs