NCT02772354

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
124

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 13, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

September 9, 2016

Status Verified

September 1, 2016

Enrollment Period

1.4 years

First QC Date

April 15, 2016

Last Update Submit

September 8, 2016

Conditions

Ventricular Arrhythmia

Keywords

Pediatric population, ablation

Outcome Measures

Primary Outcomes (1)

  • The presence of premature ventricular complexes ≥ 300 according to the 24-hour Holter ECG monitoring

    12 months

Secondary Outcomes (5)

  • Complications

    12 months

  • Left ventricle diameter

    12 months

  • Right ventricle diameter

    12 months

  • Premature ventricular complexes burden according to the 24- hour Holter ECG

    12 months

  • Ventricular tachycardia according to the 24- hour Holter ECG

    12 months

Study Arms (2)

Ablation

EXPERIMENTAL

Standard radiosurgery ablation of premature ventricular complexes using navigation system.

Procedure: Radiofrequency catheter ablationDevice: NAVI-STAR® RMT ThermoCool

Control

ACTIVE COMPARATOR

Antiarrhythmic therapy of premature ventricular complexes according to the guidlines

Drug: MetoprololDrug: Verapamil

Interventions

Radiofrequency catheter ablationPROCEDURE

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

Ablation
MetoprololDRUG

Antiarrhythmic therapy of premature ventricular complexes Metoprolol 12-50 mg

Control
VerapamilDRUG

Verapamil 20-240 mg

Control
NAVI-STAR® RMT ThermoCoolDEVICE
Ablation

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Clinical Institute of Pediatrics, N.I. Pirogov Russian National Research Medical University

Moscow, Russia

RECRUITING

State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation

Novosibirsk, 630055, Russia

RECRUITING

MeSH Terms

Interventions

Catheter AblationMetoprololVerapamil

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, OperativePhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesPhenethylaminesEthylamines

Central Study Contacts

Alexander B Romanov, MD, PhD

CONTACT

+73833327655abromanov@mail.ru

Igor L Mikheenko, MD

CONTACT

+73833327655igor.mikheenko@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2016

First Posted

May 13, 2016

Study Start

April 1, 2016

Primary Completion

September 1, 2017

Study Completion

April 1, 2018

Last Updated

September 9, 2016

Record last verified: 2016-09

Locations

RU(2)