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

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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

Tracking Information
First Submitted Date  ICMJE April 15, 2016
First Posted Date  ICMJE May 13, 2016
Last Update Posted Date September 9, 2016
Study Start Date  ICMJE April 2016
Estimated Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2016)
The presence of premature ventricular complexes ≥ 300 according to the 24-hour Holter ECG monitoring [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2016)
  • Complications [ Time Frame: 12 months ]
  • Left ventricle diameter [ Time Frame: 12 months ]
  • Right ventricle diameter [ Time Frame: 12 months ]
  • Premature ventricular complexes burden according to the 24- hour Holter ECG [ Time Frame: 12 months ]
  • Ventricular tachycardia according to the 24- hour Holter ECG [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radiofrequency Ablation of Symptomatic Frequent Ventricular Premature Complexes in Pediatric Population
Official Title  ICMJE Radiofrequency Ablation of Symptomatic Frequent Ventricular Premature Complexes as a First-line Therapy in Pediatric Population Without Structural Heart Disease
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ventricular Arrhythmia
Intervention  ICMJE
  • Procedure: Radiofrequency catheter ablation
    Biosense Webster: NAVI-STAR ThermoCool, NAVI-STAR® RMT ThermoCool
  • Drug: Metoprolol

    Antiarrhythmic therapy of premature ventricular complexes

    Metoprolol 12-50 mg

  • Drug: Verapamil
    Verapamil 20-240 mg
  • Device: NAVI-STAR® RMT ThermoCool
Study Arms  ICMJE
  • Experimental: Ablation
    Standard radiosurgery ablation of premature ventricular complexes using navigation system.
    Interventions:
    • Procedure: Radiofrequency catheter ablation
    • Device: NAVI-STAR® RMT ThermoCool
  • Active Comparator: Control
    Antiarrhythmic therapy of premature ventricular complexes according to the guidlines
    Interventions:
    • Drug: Metoprolol
    • Drug: Verapamil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 12, 2016)
124
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2018
Estimated Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02772354
Other Study ID Numbers  ICMJE ILM511
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Meshalkin Research Institute of Pathology of Circulation
Study Sponsor  ICMJE Meshalkin Research Institute of Pathology of Circulation
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Meshalkin Research Institute of Pathology of Circulation
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP