- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02772354
Radiofrequency Ablation of Symptomatic Frequent Ventricular Premature Complexes in Pediatric Population (RAS)
September 8, 2016 updated by: Meshalkin Research Institute of Pathology of Circulation
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
Status
Unknown
Conditions
Intervention / Treatment
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
- Name: Igor L Mikheenko, MD
- Phone Number: +73833327655
- Email: igor.mikheenko@gmail.com
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Arrhythmias, Cardiac
- Cardiac Conduction System Disease
- Cardiac Complexes, Premature
- Ventricular Premature Complexes
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Vasodilator Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Sympatholytics
- Adrenergic beta-1 Receptor Antagonists
- Metoprolol
- Verapamil
Other Study ID Numbers
- ILM511
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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