Ventricular TachycardiaPhase 4AVATARNCT01780311
Catheter Ablation Versus Antiarrhythmic Drugs for Outflow Tract Ventricular ARrhythmias
A Phase 4 study testing antiarrhythmic drugs (Flecainide or Propafenone or Sotalol) and Catheter Ablation in people with Ventricular Tachycardia and Ventricular Premature Complexes, run by Ospedale San Donato at 1 site in Italy.
Trial summary
A randomized, parallel, open study comparing catheter ablation versus antiarrhythmic drugs for outflow tract ventricular arrhythmias Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ventricular Tachycardia, Ventricular Premature Complexes
- What is being tested?
- antiarrhythmic drugs (Flecainide or Propafenone or Sotalol) and Catheter Ablation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteItaly
- Study dates
- Jan 2013to Jan 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- known structural heart disease
- pregnancy
- life expectancy < 1 year
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Cardiovascular Department, Ospedale S.Donato
Arezzo, AR, 52100
Pasquale Notarstefano, MD, notarstefano2001@yahoo.it
Leonardo Bolognese, MD, FESC
About this study
A randomized, parallel, open study comparing catheter ablation versus antiarrhythmic drugs for outflow tract ventricular arrhythmias
- Being tested
- antiarrhythmic drugs (Flecainide or Propafenone or Sotalol), Catheter Ablation
- Medical subject headings
- Tachycardia, Ventricular, Ventricular Premature Complexes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antiarrhythmic drugs (Flecainide or Propafenone or Sotalol)Drug
Catheter AblationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Antiarrhythmic drugs | Active comparator | Flecainide or Propafenone or Sotalol (oral, standard dosage) Receives: Drug: antiarrhythmic drugs (Flecainide or Propafenone or Sotalol) |
| ABLATION | Experimental | Catheter Ablation Receives: Procedure: Catheter Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF-36 score
Quality of life improvement according to SF-36 score variations
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
Sponsor and investigators
- Lead sponsor
- Ospedale San Donato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leonardo Bolognese, MD, Ospedale San Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01780311
- Sponsor's protocol ID
- Arezzo008
- Acronym
- AVATAR
- Status last verified
- Jan 2013
- First submitted
- 25 Jan 2013
- Last updated
- 31 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Catheter Ablation Versus Antiarrhythmic Drugs for Outflow Tract Ventricular ARrhythmias
- ClinicalTrials.gov ID
- NCT01780311
- Acronym / sponsor ID
- AVATAR / Arezzo008
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Ospedale San DonatoUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (estimated)
- First posted
- 31 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, parallel, open study comparing catheter ablation versus antiarrhythmic drugs for outflow tract ventricular arrhythmias
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antiarrhythmic drugs | Active comparator | Drug: antiarrhythmic drugs (Flecainide or Propafenone or Sotalol)Flecainide or Propafenone or Sotalol (oral, standard dosage) |
| ABLATION | Experimental | Procedure: Catheter AblationCatheter Ablation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- known structural heart disease
- pregnancy
- life expectancy < 1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antiarrhythmic drugs (Flecainide or Propafenone or Sotalol) | Drug | Antiarrhythmic drugs |
| Catheter Ablation | Procedure or surgery | ABLATION |
Primary outcome
SF-36 score
Time frame: 6 months
Quality of life improvement according to SF-36 score variations
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2013.
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Tachycardia, Ventricular
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing antiarrhythmic drugs (Flecainide or Propafenone or Sotalol) and Catheter Ablation in people with Ventricular Tachycardia and Ventricular Premature Complexes, run by Ospedale San Donato at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SF-36 score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2013.