Catheter Ablation Versus Antiarrhythmic Drugs for Outflow Tract Ventricular ARrhythmias

Phase 4

• Conditions: Ventricular Tachycardia; Ventricular Premature Complexes
• Interventions: Drug: antiarrhythmic drugs (Flecainide or Propafenone or Sotalol); Procedure: Catheter Ablation

• Registration Number: NCT01780311
• Lead Sponsor: Ospedale San Donato

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-01
• Study Start: 2013-01
• Study First Submitted: 2013-01-25
• Study First Submitted QC: 2013-01-30
• Last Update Submitted: 2013-01-30
• Study First Posted: 2013-01-31
• Last Update Posted: 2013-01-31
• Primary Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Antiarrhythmic drugs	antiarrhythmic drugs (Flecainide or Propafenone or Sotalol)	Flecainide or Propafenone or Sotalol (oral, standard dosage)
ABLATION	Catheter Ablation	Catheter Ablation

Primary Outcome Measures

Name	Time	Method
SF-36 score	6 months	Quality of life improvement according to SF-36 score variations

Trial Locations

Locations (1)

Cardiovascular Department, Ospedale S.Donato; 🇮🇹 Arezzo, AR, Italy