MedDataX Logo

Catheter Ablation Versus Antiarrhythmic Drugs for Outflow Tract Ventricular ARrhythmias

NCT ID: NCT01780311

Last Updated: 2013-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ventricular Tachycardia Ventricular Premature Complexes

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Antiarrhythmic drugs

Flecainide or Propafenone or Sotalol (oral, standard dosage)

Group Type ACTIVE_COMPARATOR

antiarrhythmic drugs (Flecainide or Propafenone or Sotalol)

Intervention Type DRUG

ABLATION

Catheter Ablation

Group Type EXPERIMENTAL

Catheter Ablation

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

antiarrhythmic drugs (Flecainide or Propafenone or Sotalol)

Intervention Type DRUG

Catheter Ablation

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ospedale San Donato

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Leonardo Bolognese, MD

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cardiovascular Department, Ospedale S.Donato

Arezzo, AR, Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Pasquale Notarstefano, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Arezzo008

Identifier Type: -

Identifier Source: org_study_id