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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatric ICD pts | Inclusion criteria for study participants included: 1) weight ≤60 kg, 2) new or existing ICD system, and 3) clinically necessary assessment of the defibrillation efficacy of the ICD system. Transvenous systems utilized a high-voltage ICD coil with active-fixation lead attached to the right ventricular endocardial surface, whereas non-transvenous systems depended upon a high-voltage shocking coil placed within the pericardial, subcutaneous or pleural space. To be included in the post-shock pacing portion of the study, adequate sinus and AV node function had to be present at baseline. Exclusion criteria included 1) tenuous hemodynamic status felt to warrant abbreviation of the defibrillation efficacy testing or 2) inability to induce fibrillation during defibrillation threshold testing (DFT). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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All patients seen by the electrophysiology service at Children's Hospital Boston who are identified to be at very high risk of sudden cardiac death and in need of an ICD
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| Name | Affiliation | Role |
|---|---|---|
| Andrew E Radbill, MD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Boston | Boston | Massachusetts | 02115 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pediatric ICD Pts | Inclusion criteria: 1) weight ≤60 kg, 2) new or existing ICD system, and 3) clinically necessary assessment of the defibrillation efficacy of the ICD system. Transvenous systems utilized a high-voltage ICD coil with active-fixation lead attached to the right ventricular endocardial surface, whereas non-transvenous systems depended upon a high-voltage shocking coil placed within the pericardial, subcutaneous or pleural space. To be included in the post-shock pacing portion of the study, adequate sinus and AV node function had to be present at baseline. Exclusion criteria included 1) tenuous hemodynamic status felt to warrant abbreviation of the defibrillation efficacy testing or 2) inability to induce fibrillation during defibrillation threshold testing (DFT). Defibrillator threshold testing: Measurement of the defibrillation threshold was performed using a modified binary search protocol. This protocol specified three distinct inductions of ventricula |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pediatric ICD Pts | Inclusion criteria: 1) weight ≤60 kg, 2) new or existing ICD system, and 3) clinically necessary assessment of the defibrillation efficacy of the ICD system. Transvenous systems utilized a high-voltage ICD coil with active-fixation lead attached to the right ventricular endocardial surface, whereas non-transvenous systems depended upon a high-voltage shocking coil placed within the pericardial, subcutaneous or pleural space. To be included in the post-shock pacing portion of the study, adequate sinus and AV node function had to be present at baseline. Exclusion criteria included 1) tenuous hemodynamic status felt to warrant abbreviation of the defibrillation efficacy testing or 2) inability to induce fibrillation during defibrillation threshold testing (DFT). Defibrillator threshold testing: Measurement of the defibrillation threshold was performed using a modified binary search protocol. This protocol specified three distinct inductions of ventricula |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Inter-Quartile Range | Joules | During clinical ICD procedure, as a single event |
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Peri-procedural (day of clinincal procedure)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pediatric ICD Pts | Inclusion criteria: 1) weight ≤60 kg, 2) new or existing ICD system, and 3) clinically necessary assessment of the defibrillation efficacy of the ICD system. Transvenous systems utilized a high-voltage ICD coil with active-fixation lead attached to the right ventricular endocardial surface, whereas non-transvenous systems depended upon a high-voltage shocking coil placed within the pericardial, subcutaneous or pleural space. To be included in the post-shock pacing portion of the study, adequate sinus and AV node function had to be present at baseline. Exclusion criteria included 1) tenuous hemodynamic status felt to warrant abbreviation of the defibrillation efficacy testing or 2) inability to induce fibrillation during defibrillation threshold testing (DFT). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrew E. Radbill | Vanderbilt University (current institution) | 615-322-7447 | andrew.radbill@vanderbilt.edu |
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| 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. |
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| During clinical ICD procedure, as a single event |
| 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 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Cardiac diagnosis | Count of Participants | Participants |
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| Weight (kg) | Median | Inter-Quartile Range | kilograms |
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| ICD system configuration | Count of Participants | Participants |
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| Location of high-voltage coil | Count of Participants | Participants |
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| Indication for defibrillation threshold testing | Count of Participants | Participants |
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| Anti-arrhythmic medications at testing | Number of anti-arrhythmic medications and number of subjects did not correlate 1:1, with 5 subjects on >1 anti-arrhythmic agent and some subjects not receiving any anti-arrhythmic agent. For this reason, the total count of anti-arrhythmic medications does not equal the subject number. | Number | participants |
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| 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). | Posted | Median | Inter-Quartile Range | Joules | During clinical ICD procedure, as a single event |
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| 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. | Post-defibrillation episodes in which intrinsic rhythm was evaluable and pacing was necessary | Posted | Number | episodes | During clinical ICD procedure, as a single event | Post-defibrillation episodes | Post-defibrillation episodes |
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| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
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