PediatricsNCT01043562
Precise Measurement of Pediatric Defibrillation Thresholds
An observational study of Pediatrics and Defibrillators, Implantable, run by Boston Children's Hospital at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pediatrics, Defibrillators, Implantable
- What is being tested?
- Defibrillator threshold testing and Observation of post-shock intrinsic cardiac rhythm
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2009to 10 May 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
Official title: Defibrillation Thresholds in a Pediatric Cohort Using Binary Search Protocol
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.
- Conditions
- Pediatrics, Defibrillators, Implantable
- Being tested
- Defibrillator threshold testing, Observation of post-shock intrinsic cardiac rhythm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Defibrillator threshold testingDiagnostic 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 rhythmOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: Defibrillator threshold testing; Other: Observation of post-shock intrinsic cardiac rhythm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During clinical ICD procedure, as a single event
Secondary outcomes (2)
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).
Measured: 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.
Measured: During clinical ICD procedure, as a single event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2010 (estimated)
- Study start4 Jun 2009
- Primary completion26 May 2010
- Study completion10 May 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PediatricsStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Eric Radbill, Boston Children's Hospital
- Investigators
- Andrew E Radbill, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01043562
- Sponsor's protocol ID
- 09-04-0209
- Status last verified
- Jul 2017
- First submitted
- 6 Jan 2010
- Last updated
- 5 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defibrillation Thresholds in a Pediatric Cohort Using Binary Search Protocol
- ClinicalTrials.gov ID
- NCT01043562
- Acronym / sponsor ID
- 09-04-0209
- Conditions
- Pediatrics, Defibrillators, Implantable
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 4 Jun 2009 (actual)
- Primary completion
- 26 May 2010 (actual)
- Study completion
- 10 May 2012 (actual)
- First posted
- 7 Jan 2010 (estimated)
- Results
- Posted 5 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric ICD pts | – | Diagnostic Test: Defibrillator threshold testing, Other: Observation of post-shock intrinsic cardiac rhythmInclusion 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Defibrillator threshold testingMeasurement 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. | Diagnostic test | Pediatric ICD pts |
| Observation of post-shock intrinsic cardiac rhythmPrior 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. | Other | Pediatric ICD pts |
Primary outcome
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.
2 secondary outcomes
Do DFTs Vary by Type of ICD Systems Implanted?
Time frame: During clinical ICD procedure, as a single event
Intrinsic Heart Rate in the Immediate Post-defibrillation Period
Time frame: During clinical ICD procedure, as a single event
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew E Radbill, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatrics and Defibrillators, Implantable, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Defibrillation Threshold (time frame: During clinical ICD procedure, as a single event). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.