Trial Outcomes & Findings for Precise Measurement of Pediatric Defibrillation Thresholds (NCT NCT01043562)
NCT ID: NCT01043562
Last Updated: 2018-02-05
Results Overview
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.
COMPLETED
20 participants
During clinical ICD procedure, as a single event
2018-02-05
Participant Flow
Participant milestones
| Measure |
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
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|---|---|
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Overall Study
STARTED
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20
|
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Overall Study
COMPLETED
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20
|
|
Overall Study
NOT COMPLETED
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0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Precise Measurement of Pediatric Defibrillation Thresholds
Baseline characteristics by cohort
| Measure |
Pediatric ICD Pts
n=20 Participants
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
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|---|---|
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Age, Continuous
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16 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
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Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
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Region of Enrollment
United States
|
20 Participants
n=99 Participants
|
|
Cardiac diagnosis
Channelopathy
|
11 Participants
n=99 Participants
|
|
Cardiac diagnosis
Congenital heart disease
|
5 Participants
n=99 Participants
|
|
Cardiac diagnosis
Cardiomyopathy
|
4 Participants
n=99 Participants
|
|
Weight (kg)
|
48 kilograms
n=99 Participants
|
|
ICD system configuration
Transvenous
|
12 Participants
n=99 Participants
|
|
ICD system configuration
Nontransvenous
|
8 Participants
n=99 Participants
|
|
Location of high-voltage coil
Transvenous single coil
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7 Participants
n=99 Participants
|
|
Location of high-voltage coil
Transveous dual coil
|
5 Participants
n=99 Participants
|
|
Location of high-voltage coil
Pericardial
|
6 Participants
n=99 Participants
|
|
Location of high-voltage coil
Subcutaneous
|
1 Participants
n=99 Participants
|
|
Location of high-voltage coil
Pleural
|
1 Participants
n=99 Participants
|
|
Indication for defibrillation threshold testing
New implant
|
7 Participants
n=99 Participants
|
|
Indication for defibrillation threshold testing
Lead revision
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5 Participants
n=99 Participants
|
|
Indication for defibrillation threshold testing
Generator change
|
5 Participants
n=99 Participants
|
|
Indication for defibrillation threshold testing
Surveillance
|
3 Participants
n=99 Participants
|
|
Anti-arrhythmic medications at testing
Beta-blocker
|
13 participants
n=99 Participants
|
|
Anti-arrhythmic medications at testing
Calcium-channel blocker
|
3 participants
n=99 Participants
|
|
Anti-arrhythmic medications at testing
Amiodarone
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2 participants
n=99 Participants
|
|
Anti-arrhythmic medications at testing
Other
|
3 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: During clinical ICD procedure, as a single eventThe 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.
Outcome measures
| Measure |
Pediatric ICD Pts
n=20 Participants
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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Non-transvenous ICDs
Patients with an implanted defibrillator system utilizing a nontransvenous high voltage coil/defibrillator lead.
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|---|---|---|
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Defibrillation Threshold
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7 Joules
Interval 4.0 to 9.0
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—
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SECONDARY outcome
Timeframe: During clinical ICD procedure, as a single eventThe 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).
Outcome measures
| Measure |
Pediatric ICD Pts
n=12 Participants
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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Non-transvenous ICDs
n=8 Participants
Patients with an implanted defibrillator system utilizing a nontransvenous high voltage coil/defibrillator lead.
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|---|---|---|
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Do DFTs Vary by Type of ICD Systems Implanted?
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7 Joules
Interval 4.5 to 11.0
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6 Joules
Interval 3.5 to 9.0
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SECONDARY outcome
Timeframe: During clinical ICD procedure, as a single eventPopulation: Post-defibrillation episodes in which intrinsic rhythm was evaluable and pacing was necessary
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.
Outcome measures
| Measure |
Pediatric ICD Pts
n=49 Post-defibrillation episodes
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).
|
Non-transvenous ICDs
Patients with an implanted defibrillator system utilizing a nontransvenous high voltage coil/defibrillator lead.
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|---|---|---|
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Intrinsic Heart Rate in the Immediate Post-defibrillation Period
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0 episodes
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—
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Adverse Events
Pediatric ICD Pts
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Andrew E. Radbill
Vanderbilt University (current institution)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place