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NCT01043562 · ClinicalTrials.gov registry record

Precise Measurement of Pediatric Defibrillation Thresholds

A clinical trial, sponsored by Boston Children's Hospital.

Completed
Registry status
20
Enrollment target

NCT01043562: Completed study, sponsored by Boston Children's Hospital.

NCT01043562 is a clinical trial that has completed, run by Boston Children's Hospital. The registered enrollment target is 20 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01043562 has completed, sponsored by Boston Children's Hospital.

COMPLETED
Registry status
20 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

  • DIAGNOSTIC_TEST Defibrillator threshold testing
  • OTHER Observation of post-shock intrinsic cardiac rhythm

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2009-06-04
Est. Completion 2012-05-10
Boston Children's Hospital

462 total trials

What the finished NCT01043562 record still lists

NCT01043562 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target.

The record links to 0 conditions, and to 2 interventions - of which Defibrillator threshold testing is the first listed.

NCT01043562 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01043562 about?

NCT01043562 is a clinical study titled "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 pedi...

What is the current status of trial NCT01043562?

This trial is currently completed. The enrollment target is 20 participants. The study started on 2009-06-04. Estimated completion is 2012-05-10.

What interventions are being tested in trial NCT01043562?

The interventions under investigation include: Defibrillator threshold testing (DIAGNOSTIC_TEST), Observation of post-shock intrinsic cardiac rhythm (OTHER).

Who is sponsoring clinical trial NCT01043562?

This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01043562, the US trial registry maintained by the National Library of Medicine. NCT01043562 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.