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

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

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

124

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Alexander B Romanov, MD, PhD
  • Phone Number: +73833327655
  • Email: abromanov@mail.ru

Study Contact Backup

Study Locations

      • Moscow, Russian Federation
        • Recruiting
        • Research Clinical Institute of Pediatrics, N.I. Pirogov Russian National Research Medical University
        • Contact:
          • Sergey Termosesov, MD, PhD
      • Novosibirsk, Russian Federation, 630055
        • Recruiting
        • State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation
        • Principal Investigator:
          • Igor L Miheenko, MD
        • Sub-Investigator:
          • Evgeny Pokushalov, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ablation
Standard radiosurgery ablation of premature ventricular complexes using navigation system.
Biosense Webster: NAVI-STAR ThermoCool, NAVI-STAR® RMT ThermoCool
ACTIVE_COMPARATOR: Control
Antiarrhythmic therapy of premature ventricular complexes according to the guidlines

Antiarrhythmic therapy of premature ventricular complexes

Metoprolol 12-50 mg

Verapamil 20-240 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The presence of premature ventricular complexes ≥ 300 according to the 24-hour Holter ECG monitoring
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Complications
Time Frame: 12 months
12 months
Left ventricle diameter
Time Frame: 12 months
12 months
Right ventricle diameter
Time Frame: 12 months
12 months
Premature ventricular complexes burden according to the 24- hour Holter ECG
Time Frame: 12 months
12 months
Ventricular tachycardia according to the 24- hour Holter ECG
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (ANTICIPATED)

September 1, 2017

Study Completion (ANTICIPATED)

April 1, 2018

Study Registration Dates

First Submitted

April 15, 2016

First Submitted That Met QC Criteria

May 12, 2016

First Posted (ESTIMATE)

May 13, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

September 9, 2016

Last Update Submitted That Met QC Criteria

September 8, 2016

Last Verified

September 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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