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NCT01780311 Clinical Trial

Catheter Ablation Versus Antiarrhythmic Drugs for Outflow Tract Ventricular ARrhythmias

Ventricular Tachycardia Clinical Trial

— AVATAR  

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01780311
Other study ID # Arezzo008
Secondary ID
Status Recruiting
Phase Phase 4
First received January 25, 2013
Last updated January 30, 2013
Start date January 2013

Study information
Verified date January 2013
Source Ospedale San Donato
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 0
Est. completion date
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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 Design

N/A

Related Conditions & MeSH terms

Intervention

Drug:
• antiarrhythmic drugs (Flecainide or Propafenone or Sotalol)

Procedure:
• Catheter Ablation

Locations
Country Name City State
Italy Cardiovascular Department, Ospedale S.Donato Arezzo AR

Sponsors (1)
Lead Sponsor Collaborator
Ospedale San Donato

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary SF-36 score Quality of life improvement according to SF-36 score variations 6 months No
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