Pediatrics Clinical Trial
Official title:
Defibrillation Thresholds in a Pediatric Cohort Using Binary Search Protocol
Verified date | July 2017 |
Source | Boston Children’s Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | May 10, 2012 |
Est. primary completion date | May 26, 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital Boston | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston Children’s Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Defibrillation Threshold | 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. | During clinical ICD procedure, as a single event | |
Secondary | Do DFTs Vary by Type of ICD Systems Implanted? | 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). | During clinical ICD procedure, as a single event | |
Secondary | Intrinsic Heart Rate in the Immediate Post-defibrillation Period | 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. | During clinical ICD procedure, as a single event |
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