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

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

NCT02772354

ILM511

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

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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