Precise Measurement of Pediatric Defibrillation Thresholds

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Children's Hospital Boston.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01043562
First received: January 6, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted

January 6, 2010
January 6, 2010
June 2009
June 2010   (final data collection date for primary outcome measure)
Defibrillation threshold as measured by the binary search protocol [ Time Frame: During clinical ICD procedure, as a single event ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Do DFTs vary amongst pediatric patients who have had different types of ICD systems implanted? [ Time Frame: During clinical ICD procedure, as a single event ] [ Designated as safety issue: No ]
  • How often do these pediatric patients have intrinsic slow heart rate and default to pacing in the immediate post-defibrillation period? [ Time Frame: During clinical ICD procedure, as a single event ] [ Designated as safety issue: No ]
Same as current
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Not Provided
 
Precise Measurement of Pediatric Defibrillation Thresholds
Defibrillation Thresholds in a Pediatric Cohort Using Binary Search Protocol

Patients who receive an implantable cardioverter-defibrillator (ICD) usually undergo testing at the end of the ICD procedure to measure the amount of energy able to successfully defibrillate the heart (defibrillation threshold testing, or DFT). This study proposes to perform that measurement in pediatric patients already undergoing clinically necessary ICD procedures, with the measurement performed using a binary search method that has been previously validated in adult cohorts. We hypothesize that pediatric DFTs, when precisely measured, may be lower than previously assumed from extrapolation of adult data.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

All patients seen by the electrophysiology service at Children's Hospital Boston who are identified to be at very high risk of sudden cardiac death and in need of an ICD

  • Pediatrics
  • Defibrillators, Implantable
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Pediatric ICD pts
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
June 2010
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Current follow-up at Children's Hospital Boston
  • Children with current or planned ICDs who are scheduled by their primary electrophysiologist for clinically necessary assessment/re-assessment of defibrillation threshold
  • If the patient has an ICD system with a non-transvenous shock coil: weight ≤35kg at time of initial implant, with current weight <50kg
  • If the patient has an ICD system with a conventional transvenous shock coil: current weight ≤60kg

Exclusion Criteria:

  • Clinical failure of any system component not able to be addressed by hardware repair or exchange
  • Hemodynamic instability that in the judgment of the primary electrophysiologist warrants abbreviation of DFT assessment
  • Unsuccessful induction of fibrillation during DFT testing
Both
Not Provided
No
United States
 
NCT01043562
09-04-0209
No
Andrew Radbill, MD, Department of Cardiology
Children's Hospital Boston
Not Provided
Principal Investigator: Andrew E Radbill, MD Children's Hospital Boston
Children's Hospital Boston
January 2010

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