Catheter Ablation Versus Antiarrhythmic Drugs for Outflow Tract Ventricular ARrhythmias (AVATAR)
This study is currently recruiting participants.
Verified January 2013 by Ospedale San Donato
Sponsor:
Ospedale San Donato
Information provided by (Responsible Party):
Leonardo Bolognese, MD, Ospedale San Donato
ClinicalTrials.gov Identifier:
NCT01780311
First received: January 25, 2013
Last updated: January 30, 2013
Last verified: January 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
A randomized, parallel, open study comparing catheter ablation versus antiarrhythmic drugs for outflow tract ventricular arrhythmias
| Condition | Intervention | Phase |
|---|---|---|
|
Ventricular Tachycardia Ventricular Premature Complexes |
Drug: antiarrhythmic drugs (Flecainide or Propafenone or Sotalol) Procedure: Catheter Ablation |
Phase 4 |
| Study Type: | Interventional |
Resource links provided by NLM:
MedlinePlus related topics:
Arrhythmia
Drug Information available for:
Sotalol hydrochloride
Sotalol
Propafenone hydrochloride
Propafenone
Flecainide
Flecainide acetate
U.S. FDA Resources
Further study details as provided by Ospedale San Donato:
Primary Outcome Measures:
- SF-36 score [ Time Frame: 6 months ] [ Designated as safety issue: No ]Quality of life improvement according to SF-36 score variations
| Study Start Date: | January 2013 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01780311
Locations
| Italy | |
| Cardiovascular Department, Ospedale S.Donato | Recruiting |
| Arezzo, AR, Italy, 52100 | |
| Contact: Pasquale Notarstefano, MD notarstefano2001@yahoo.it | |
| Principal Investigator: Leonardo Bolognese, MD, FESC | |
| Principal Investigator: Pasquale Notarstefano, MD | |
| Sub-Investigator: Simone Grotti | |
Sponsors and Collaborators
Ospedale San Donato
More Information
No publications provided
| Responsible Party: | Leonardo Bolognese, MD, Director, Ospedale San Donato |
| ClinicalTrials.gov Identifier: | NCT01780311 History of Changes |
| Other Study ID Numbers: | Arezzo008 |
| Study First Received: | January 25, 2013 |
| Last Updated: | January 30, 2013 |
| Health Authority: | Italy: Ethics Committee |
Additional relevant MeSH terms:
|
Tachycardia Tachycardia, Ventricular Ventricular Premature Complexes Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Cardiac Complexes, Premature Anti-Arrhythmia Agents Propafenone Flecainide Sotalol |
Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Sympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013