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Radiofrequency Ablation of Symptomatic Frequent Ventricular Premature Complexes in Pediatric Population

Radiofrequency Ablation of Symptomatic Frequent Ventricular Premature Complexes as a First-line Therapy in Pediatric Population Without Structural Heart Disease

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02772354
Acronym
RAS
Enrollment
124
Registered
2016-05-13
Start date
2016-04-30
Completion date
2018-04-30
Last updated
2016-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventricular Arrhythmia

Keywords

Pediatric population, ablation

Brief 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.

Interventions

PROCEDURERadiofrequency catheter ablation

Biosense Webster: NAVI-STAR ThermoCool, NAVI-STAR® RMT ThermoCool

DRUGMetoprolol

Antiarrhythmic therapy of premature ventricular complexes Metoprolol 12-50 mg

DRUGVerapamil

Verapamil 20-240 mg

DEVICENAVI-STAR® RMT ThermoCool

Sponsors

Meshalkin Research Institute of Pathology of Circulation
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
7 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* Symptomatic, frequent, premature ventricular complexes (more than 10,000 according to the 24 hour Holter ECG)

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frame
The presence of premature ventricular complexes ≥ 300 according to the 24-hour Holter ECG monitoring12 months

Secondary

MeasureTime frame
Complications12 months
Left ventricle diameter12 months
Right ventricle diameter12 months
Premature ventricular complexes burden according to the 24- hour Holter ECG12 months
Ventricular tachycardia according to the 24- hour Holter ECG12 months

Countries

Russia

Contacts

Primary ContactAlexander B Romanov, MD, PhD
abromanov@mail.ru+73833327655
Backup ContactIgor L Mikheenko, MD
igor.mikheenko@gmail.com+73833327655

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026