ClinicalTrials.Veeva

Menu

Radiofrequency Ablation of Symptomatic Frequent Ventricular Premature Complexes in Pediatric Population (RAS)

M

Meshalkin Research Institute of Pathology of Circulation

Status and phase

Unknown
Phase 3
Phase 2

Conditions

Ventricular Arrhythmia

Treatments

Drug: Metoprolol
Device: NAVI-STAR® RMT ThermoCool
Drug: Verapamil
Procedure: Radiofrequency catheter ablation

Study type

Interventional

Funder types

NETWORK

Identifiers

Details and patient eligibility

About

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.

Enrollment

124 estimated patients

Sex

All

Ages

7 to 18 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

124 participants in 2 patient groups

Ablation
Experimental group
Description:
Standard radiosurgery ablation of premature ventricular complexes using navigation system.
Treatment:
Device: NAVI-STAR® RMT ThermoCool
Procedure: Radiofrequency catheter ablation
Control
Active Comparator group
Description:
Antiarrhythmic therapy of premature ventricular complexes according to the guidlines
Treatment:
Drug: Metoprolol
Drug: Verapamil

Trial contacts and locations

2

Loading...

Central trial contact

Igor L Mikheenko, MD; Alexander B Romanov, MD, PhD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems