Precise Measurement of Pediatric Defibrillation Thresholds
Completed
Conditions studied: Pediatrics, Defibrillators, Implantable
In brief
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.
Key facts
- Study ID
- NCT01043562
- Run by
- Boston Children's Hospital
- People needed
- 20
- Starts
- 2009-06-04
- Expected to finish
- 2012-05-10
- Last updated by the study team
- 2018-02-05
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Children's Hospital Boston — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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