Radiofrequency Ablation of Symptomatic Frequent Ventricular Premature Complexes in Pediatric Population

Ventricular Arrhythmia Clinical Trial

— RAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02772354
• Other study ID #: ILM511
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: April 15, 2016
• Last updated: September 8, 2016
• Start date: April 2016
• Est. completion date: April 2018

Study information

• Verified date: September 2016
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: Alexander B Romanov, MD, PhD
• Phone: +73833327655
• Email: abromanov[@]mail.ru
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: April 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ventricular Arrhythmia
• Ventricular Premature Complexes

Intervention

Procedure:
• Radiofrequency catheter ablation
Biosense Webster: NAVI-STAR ThermoCool, NAVI-STAR® RMT ThermoCool

Drug:
• Metoprolol
Antiarrhythmic therapy of premature ventricular complexes Metoprolol 12-50 mg
• Verapamil
Verapamil 20-240 mg

Device:
• NAVI-STAR® RMT ThermoCool

Locations

Country	Name	City	State
Russian Federation	Research Clinical Institute of Pediatrics, N.I. Pirogov Russian National Research Medical University	Moscow
Russian Federation	State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The presence of premature ventricular complexes = 300 according to the 24-hour Holter ECG monitoring		12 months	Yes
Secondary	Complications		12 months	Yes
Secondary	Left ventricle diameter		12 months	Yes
Secondary	Right ventricle diameter		12 months	Yes
Secondary	Premature ventricular complexes burden according to the 24- hour Holter ECG		12 months	Yes
Secondary	Ventricular tachycardia according to the 24- hour Holter ECG		12 months	Yes