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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02772354
Recruitment Status : Unknown
Verified September 2016 by Meshalkin Research Institute of Pathology of Circulation.
Recruitment status was:  Recruiting
First Posted : May 13, 2016
Last Update Posted : September 9, 2016
Sponsor:
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation

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.

Condition or disease Intervention/treatment Phase
Ventricular Arrhythmia Procedure: Radiofrequency catheter ablation Drug: Metoprolol Drug: Verapamil Device: NAVI-STAR® RMT ThermoCool Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Radiofrequency Ablation of Symptomatic Frequent Ventricular Premature Complexes as a First-line Therapy in Pediatric Population Without Structural Heart Disease
Study Start Date : April 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : April 2018

Arm Intervention/treatment
Experimental: Ablation
Standard radiosurgery ablation of premature ventricular complexes using navigation system.
Procedure: Radiofrequency catheter ablation
Biosense Webster: NAVI-STAR ThermoCool, NAVI-STAR® RMT ThermoCool

Device: NAVI-STAR® RMT ThermoCool
Active Comparator: Control
Antiarrhythmic therapy of premature ventricular complexes according to the guidlines
Drug: Metoprolol

Antiarrhythmic therapy of premature ventricular complexes

Metoprolol 12-50 mg


Drug: Verapamil
Verapamil 20-240 mg




Primary Outcome Measures :
  1. The presence of premature ventricular complexes ≥ 300 according to the 24-hour Holter ECG monitoring [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Complications [ Time Frame: 12 months ]
  2. Left ventricle diameter [ Time Frame: 12 months ]
  3. Right ventricle diameter [ Time Frame: 12 months ]
  4. Premature ventricular complexes burden according to the 24- hour Holter ECG [ Time Frame: 12 months ]
  5. Ventricular tachycardia according to the 24- hour Holter ECG [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02772354


Contacts
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Contact: Alexander B Romanov, MD, PhD +73833327655 abromanov@mail.ru
Contact: Igor L Mikheenko, MD +73833327655 igor.mikheenko@gmail.com

Locations
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Russian Federation
Research Clinical Institute of Pediatrics, N.I. Pirogov Russian National Research Medical University Recruiting
Moscow, Russian Federation
Contact: Sergey Termosesov, MD, PhD         
State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation Recruiting
Novosibirsk, Russian Federation, 630055
Contact: Evgeny Pokushalov, MD, PhD    +79139254858    E.Pokushalov@gmail.com   
Principal Investigator: Igor L Miheenko, MD         
Sub-Investigator: Alexander Romanov, MD, PhD         
Sub-Investigator: Evgeny Pokushalov, MD, PhD         
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation
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Responsible Party: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT02772354    
Other Study ID Numbers: ILM511
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: September 9, 2016
Last Verified: September 2016
Keywords provided by Meshalkin Research Institute of Pathology of Circulation:
Pediatric population, ablation
Additional relevant MeSH terms:
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Ventricular Premature Complexes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cardiac Complexes, Premature
Cardiac Conduction System Disease
Metoprolol
Verapamil
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents