AVATAR: Catheter Ablation Versus Antiarrhythmic Drugs for Outflow Tract Ventricular ARrhythmias

• Sponsor: Ospedale San Donato (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01780311
• Collaborator: (none)
• Location: 1
• Arms: 2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Ventricular Tachycardia; Ventricular Premature Complexes	Drug: antiarrhythmic drugs (Flecainide or Propafenone or Sotalol); Procedure: Catheter Ablation	Phase 4

Study Design

• Study Type: Interventional
• Study Start Date: Jan 1, 2013
• Anticipated Primary Completion Date: Jan 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. SF-36 score [6 months]

   Quality of life improvement according to SF-36 score variations

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

2. 2000 isolated VEB/24h

3. symptomatic monomorphic ventricular tachycardia

4. 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

Locations

	Site	City	State	Country	Postal Code
1	Cardiovascular Department, Ospedale S.Donato	Arezzo	AR	Italy	52100

Sponsors and Collaborators

• Ospedale San Donato

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Leonardo Bolognese, MD, Director, Ospedale San Donato
• ClinicalTrials.gov Identifier: NCT01780311
• Other Study ID Numbers: Arezzo008
• First Posted: Jan 31, 2013
• Last Update Posted: Jan 31, 2013
• Last Verified: Jan 1, 2013

• Additional relevant MeSH terms: Tachycardia; Tachycardia, Ventricular; Ventricular Premature Complexes; Sotalol; Flecainide; Anti-Arrhythmia Agents; Propafenone

Study Results

No Results Posted as of Jan 31, 2013