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

Primary Purpose

Ventricular Arrhythmia

Status
Unknown status
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
Radiofrequency catheter ablation
Metoprolol
Verapamil
NAVI-STAR® RMT ThermoCool
Sponsored by
Meshalkin Research Institute of Pathology of Circulation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventricular Arrhythmia focused on measuring Pediatric population, ablation

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • Research Clinical Institute of Pediatrics, N.I. Pirogov Russian National Research Medical UniversityRecruiting
  • State Research Institute of CIrculation Pathology Novosibirsk, Russian FederationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ablation

Control

Arm Description

Standard radiosurgery ablation of premature ventricular complexes using navigation system.

Antiarrhythmic therapy of premature ventricular complexes according to the guidlines

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Complications
Left ventricle diameter
Right ventricle diameter
Premature ventricular complexes burden according to the 24- hour Holter ECG
Ventricular tachycardia according to the 24- hour Holter ECG

Full Information

First Posted
April 15, 2016
Last Updated
September 8, 2016
Sponsor
Meshalkin Research Institute of Pathology of Circulation
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1. Study Identification

Unique Protocol Identification Number
NCT02772354
Brief Title
Radiofrequency Ablation of Symptomatic Frequent Ventricular Premature Complexes in Pediatric Population
Acronym
RAS
Official Title
Radiofrequency Ablation of Symptomatic Frequent Ventricular Premature Complexes as a First-line Therapy in Pediatric Population Without Structural Heart Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
April 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Arrhythmia
Keywords
Pediatric population, ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ablation
Arm Type
Experimental
Arm Description
Standard radiosurgery ablation of premature ventricular complexes using navigation system.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Antiarrhythmic therapy of premature ventricular complexes according to the guidlines
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency catheter ablation
Intervention Description
Biosense Webster: NAVI-STAR ThermoCool, NAVI-STAR® RMT ThermoCool
Intervention Type
Drug
Intervention Name(s)
Metoprolol
Intervention Description
Antiarrhythmic therapy of premature ventricular complexes Metoprolol 12-50 mg
Intervention Type
Drug
Intervention Name(s)
Verapamil
Intervention Description
Verapamil 20-240 mg
Intervention Type
Device
Intervention Name(s)
NAVI-STAR® RMT ThermoCool
Primary Outcome Measure Information:
Title
The presence of premature ventricular complexes ≥ 300 according to the 24-hour Holter ECG monitoring
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Complications
Time Frame
12 months
Title
Left ventricle diameter
Time Frame
12 months
Title
Right ventricle diameter
Time Frame
12 months
Title
Premature ventricular complexes burden according to the 24- hour Holter ECG
Time Frame
12 months
Title
Ventricular tachycardia according to the 24- hour Holter ECG
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander B Romanov, MD, PhD
Phone
+73833327655
Email
abromanov@mail.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Igor L Mikheenko, MD
Phone
+73833327655
Email
igor.mikheenko@gmail.com
Facility Information:
Facility Name
Research Clinical Institute of Pediatrics, N.I. Pirogov Russian National Research Medical University
City
Moscow
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergey Termosesov, MD, PhD
Facility Name
State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evgeny Pokushalov, MD, PhD
Phone
+79139254858
Email
E.Pokushalov@gmail.com
First Name & Middle Initial & Last Name & Degree
Igor L Miheenko, MD
First Name & Middle Initial & Last Name & Degree
Alexander Romanov, MD, PhD
First Name & Middle Initial & Last Name & Degree
Evgeny Pokushalov, MD, PhD

12. IPD Sharing Statement

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Radiofrequency Ablation of Symptomatic Frequent Ventricular Premature Complexes in Pediatric Population

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