NCT01780311

Brief Summary

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

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 31, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Last Updated

January 31, 2013

Status Verified

January 1, 2013

Enrollment Period

1 year

First QC Date

January 25, 2013

Last Update Submit

January 30, 2013

Conditions

Ventricular TachycardiaVentricular Premature Complexes

Outcome Measures

Primary Outcomes (1)

  • SF-36 score

    Quality of life improvement according to SF-36 score variations

    6 months

Study Arms (2)

Antiarrhythmic drugs

ACTIVE COMPARATOR

Flecainide or Propafenone or Sotalol (oral, standard dosage)

Drug: antiarrhythmic drugs (Flecainide or Propafenone or Sotalol)

ABLATION

EXPERIMENTAL

Catheter Ablation

Procedure: Catheter Ablation

Interventions

antiarrhythmic drugs (Flecainide or Propafenone or Sotalol)DRUG
Antiarrhythmic drugs
Catheter AblationPROCEDURE
ABLATION

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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

You may not qualify if:

  • known structural heart disease
  • pregnancy
  • life expectancy \< 1 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Department, Ospedale S.Donato

Arezzo, AR, 52100, Italy

RECRUITING

MeSH Terms

Conditions

Tachycardia, VentricularVentricular Premature Complexes

Interventions

Anti-Arrhythmia AgentsFlecainidePropafenoneSotalolCatheter Ablation

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and SymptomsCardiac Complexes, Premature

Intervention Hierarchy (Ancestors)

Cardiovascular AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPropiophenonesKetonesOrganic ChemicalsEthanolaminesAmino AlcoholsAlcoholsAminesRadiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
phase 4
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

January 25, 2013

First Posted

January 31, 2013

Study Start

January 1, 2013

Primary Completion

January 1, 2014

Last Updated

January 31, 2013

Record last verified: 2013-01

Locations

IT(1)