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Completed

NCT Number: NCT01043562

Precise Measurement of Pediatric Defibrillation Thresholds

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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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Defibrillator threshold testing

Diagnostic Test

Measurement of the defibrillation threshold was performed using a modified binary search protocol. This protocol specified three distinct inductions of ventricular fibrillation (VF) for all subjects, with a 3-5 minute observation/waiting period between inductions. The initial shock energy was programmed at 9 joules (J) for all patients, with internal rescue shocks at 31J followed by device-specific maximum deliverable energy. The outcome of the initial induction determined the programmed energies for both the initial and internal rescue shocks for the second induction, and likewise for the third induction. All shocks were biphasic and delivered at manufacturers' default tilt, polarity and duration, and all final programmed shock vectors included an active can. External defibrillation pads were in place for delivery of external rescue shock should the internal shocks fail.

Observation of post-shock intrinsic cardiac rhythm

Other

Prior to each of the three ventricular fibrillation inductions performed as part of the binary search protocol, post-shock pacing was re-programmed using a pre-determined, stepwise protocol that progressively decreased the lower rate limit. For the purpose of this protocol, post-shock pacing was considered necessary if 1) ≥7 ventricular-paced beats or 2) asystole >4 seconds was observed in the first 20 seconds after defibrillation, or if the systolic blood pressure demonstrated a >10% decrease from pre-induction baseline at follow-up measurement 1 minute post-defibrillation. Rescue ventricular pacing via the programmer was available for all subjects.

Primary outcomes

  1. Defibrillation Threshold

    Time frame: During clinical ICD procedure, as a single event

    The defibrillation threshold is a measure of the minimum amount of energy (in Joules) that is able to successfully defibrillate an episode of ventricular fibrillation. This measurement is specific to each individual patient with his/her specific defibrillator configuration. There are several different strategies to measuring this in an individual patient; this study utilized the binary search protocol.

Secondary outcomes

  1. Do DFTs Vary by Type of ICD Systems Implanted?

    Time frame: During clinical ICD procedure, as a single event

    The defibrillation threshold (as measured in Joules as already described in the details regarding the primary outcome) will be compared between patients with two distinct general types of implanted defibrillator systems: 1) transvenous ICD systems (defibrillator leads located inside the vein and attached to the endocardial surface of the heart) and 2) non-transvenous ICD systems (including all other types of debrillation systems).

  2. Intrinsic Heart Rate in the Immediate Post-defibrillation Period

    Time frame: During clinical ICD procedure, as a single event

    A patient will be considered to have an intrinsic slow heart rate in the period of time immediately following defibrillation (20 seconds) if any of the following are observed: >7 paced beats, asystole >4 seconds, or experienced >10% decrease in systolic blood pressure.

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

Defibrillation Thresholds in a Pediatric Cohort Using Binary Search Protocol

Important dates

Study start
2009
Primary completion
2010
Study completion
2012
First posted
Jan 7, 2010
Registry last updated
Feb 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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