Radiofrequency Ablation of Symptomatic Frequent Ventricular Premature Complexes in Pediatric Population

Phase 2

• Conditions: Ventricular Arrhythmia
• Interventions: Procedure: Radiofrequency catheter ablation; Drug: Metoprolol; Device: NAVI-STAR® RMT ThermoCool; Drug: Verapamil

• Registration Number: NCT02772354
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-15
• Study First Submitted QC: 2016-05-12
• Study First Posted: 2016-05-13
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-08
• Last Update Posted: 2016-09-09
• Primary Completion: 2017-09
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 124

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ablation	Radiofrequency catheter ablation	Standard radiosurgery ablation of premature ventricular complexes using navigation system.
Ablation	NAVI-STAR® RMT ThermoCool	Standard radiosurgery ablation of premature ventricular complexes using navigation system.
Control	Metoprolol	Antiarrhythmic therapy of premature ventricular complexes according to the guidlines
Control	Verapamil	Antiarrhythmic therapy of premature ventricular complexes according to the guidlines

Primary Outcome Measures

Name	Time	Method
The presence of premature ventricular complexes ≥ 300 according to the 24-hour Holter ECG monitoring	12 months

Secondary Outcome Measures

Name	Time	Method
Complications	12 months
Left ventricle diameter	12 months
Premature ventricular complexes burden according to the 24- hour Holter ECG	12 months
Right ventricle diameter	12 months
Ventricular tachycardia according to the 24- hour Holter ECG	12 months

Trial Locations

Locations (2)

State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation; 🇷🇺 Novosibirsk, Russian Federation

Research Clinical Institute of Pediatrics, N.I. Pirogov Russian National Research Medical University; 🇷🇺 Moscow, Russian Federation