N/A
Completed N=20
Precise Measurement of Pediatric Defibrillation Thresholds
Pediatrics · Defibrillators, Implantable
Source: ClinicalTrials.gov NCT01043562 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcomePrimary: Defibrillation Threshold — 7 Joules
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Defibrillation Threshold |
7 | — |
| SECONDARY Do DFTs Vary by Type of ICD Systems Implanted? |
7; 6 | — |
| SECONDARY Intrinsic Heart Rate in the Immediate Post-defibrillation Period |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01043562). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.