Ventricular ArrhythmiaPhase 2/3RASNCT02772354
Radiofrequency Ablation of Symptomatic Frequent Ventricular Premature Complexes in Pediatric Population
A Phase 2/3 study testing Radiofrequency catheter ablation, Metoprolol and Verapamil in people with Ventricular Arrhythmia, run by Meshalkin Research Institute of Pathology of Circulation at 2 sites in Russia.
Trial summary
To evaluate the effectiveness and safety of catheter ablation of frequent symptomatic PVCs in the pediatric population as first-line therapy compared with antiarrhythmic drugs. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Ventricular Arrhythmia
- What is being tested?
- Radiofrequency catheter ablation, Metoprolol and Verapamil
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 2 sitesRussia
- Study dates
- Apr 2016to Apr 2018
- Phase
- Phase 2/3
- 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Symptomatic, frequent, premature ventricular complexes (more than 10,000 according to the 24 hour Holter ECG)
Who cannot join
- Antiarrhythmic therapy before inclusion Structural heart pathology requiring surgical correction; Premature ventricular complexes associated with structural heart disease; Previously performed radiofrequency ablation due to premature ventricular complexes.
Trial locations and contacts
2 sites in 1 country.
Russia2 sites, 2 recruiting
- Recruiting
Research Clinical Institute of Pediatrics, N.I. Pirogov Russian National Research Medical University
Moscow
Sergey Termosesov, MD, PhD
- Recruiting
State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation
Novosibirsk, 630055
Evgeny Pokushalov, MD, PhD, +79139254858, E.Pokushalov@gmail.com
Igor L Miheenko, MD
About this study
Official title: Radiofrequency Ablation of Symptomatic Frequent Ventricular Premature Complexes as a First-line Therapy in Pediatric Population Without Structural Heart Disease
To evaluate the effectiveness and safety of catheter ablation of frequent symptomatic PVCs in the pediatric population as first-line therapy compared with antiarrhythmic drugs.
- Conditions
- Ventricular Arrhythmia
- Being tested
- Radiofrequency catheter ablation, Metoprolol, Verapamil, NAVI-STAR® RMT ThermoCool
- Keywords
- Pediatric population, ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency catheter ablationProcedure or surgery
Biosense Webster: NAVI-STAR ThermoCool, NAVI-STAR® RMT ThermoCool
MetoprololDrug
Antiarrhythmic therapy of premature ventricular complexes
Metoprolol 12-50 mg
VerapamilDrug
Verapamil 20-240 mg
NAVI-STAR® RMT ThermoCoolDevice
| Study group | Role | What they receive |
|---|---|---|
| Ablation | Experimental | Standard radiosurgery ablation of premature ventricular complexes using navigation system. Receives: Procedure: Radiofrequency catheter ablation; Device: NAVI-STAR® RMT ThermoCool |
| Control | Active comparator | Antiarrhythmic therapy of premature ventricular complexes according to the guidlines Receives: Drug: Metoprolol; Drug: Verapamil |
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence of premature ventricular complexes ≥ 300 according to the 24-hour Holter ECG monitoring
Measured: 12 months
Secondary outcomes (5)
Complications
Measured: 12 months
Left ventricle diameter
Measured: 12 months
Right ventricle diameter
Measured: 12 months
Premature ventricular complexes burden according to the 24- hour Holter ECG
Measured: 12 months
Ventricular tachycardia according to the 24- hour Holter ECG
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startApr 2016
- Primary completionSep 2017 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular ArrhythmiaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02772354
- Sponsor's protocol ID
- ILM511
- Acronym
- RAS
- Status last verified
- Sep 2016
- First submitted
- 15 Apr 2016
- Last updated
- 9 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Ablation of Symptomatic Frequent Ventricular Premature Complexes as a First-line Therapy in Pediatric Population Without Structural Heart Disease
- ClinicalTrials.gov ID
- NCT02772354
- Acronym / sponsor ID
- RAS / ILM511
- Conditions
- Ventricular Arrhythmia
- Keywords
- Pediatric population, ablation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- Apr 2016
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 13 May 2016 (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.
To evaluate the effectiveness and safety of catheter ablation of frequent symptomatic PVCs in the pediatric population as first-line therapy compared with antiarrhythmic drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ablation | Experimental | Procedure: Radiofrequency catheter ablation, Device: NAVI-STAR® RMT ThermoCoolStandard radiosurgery ablation of premature ventricular complexes using navigation system. |
| Control | Active comparator | Drug: Metoprolol, Drug: VerapamilAntiarrhythmic therapy of premature ventricular complexes according to the guidlines |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Symptomatic, frequent, premature ventricular complexes (more than 10,000 according to the 24 hour Holter ECG)
Key exclusion criteria (1 listed)
- Antiarrhythmic therapy before inclusion Structural heart pathology requiring surgical correction; Premature ventricular complexes associated with structural heart disease; Previously performed radiofrequency ablation due to premature ventricular complexes.
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 |
|---|---|---|
| Radiofrequency catheter ablationBiosense Webster: NAVI-STAR ThermoCool, NAVI-STAR® RMT ThermoCool | Procedure or surgery | Ablation |
| MetoprololAntiarrhythmic therapy of premature ventricular complexes Metoprolol 12-50 mg | Drug | Control |
| VerapamilVerapamil 20-240 mg | Drug | Control |
| NAVI-STAR® RMT ThermoCool | Device | Ablation |
Primary outcome
The presence of premature ventricular complexes ≥ 300 according to the 24-hour Holter ECG monitoring
Time frame: 12 months
5 secondary outcomes
Complications
Time frame: 12 months
Left ventricle diameter
Time frame: 12 months
Right ventricle diameter
Time frame: 12 months
Premature ventricular complexes burden according to the 24- hour Holter ECG
Time frame: 12 months
Ventricular tachycardia according to the 24- hour Holter ECG
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2016.
Related trials for Ventricular Arrhythmia
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VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Enrolling by invitation
EDEN Intracardiac Electrogram Recording and Classifying System
Ventricular Arrhythmia
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
RecruitingObservational study
Physical Impairments in Premature Ventricular Complex
Premature Ventricular Complexes
Recruiting
A Study of Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter With the TRUPULSE™ Generator for Treatment of Ventricular Arrhythmias
Arrhythmias, Cardiac
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Radiofrequency catheter ablation, Metoprolol and Verapamil in people with Ventricular Arrhythmia, run by Meshalkin Research Institute of Pathology of Circulation at 2 sites in Russia.
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 1 inclusion and 1 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 9 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Alexander B Romanov, MD, PhD (+73833327655, abromanov@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The presence of premature ventricular complexes ≥ 300 according to the 24-hour Holter ECG monitoring (time frame: 12 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 9 Sep 2016.