Precise Measurement of Pediatric Defibrillation Thresholds

• ClinicalTrials.gov Identifier: NCT01043562
• Recruitment Status: Completed
• First Posted: January 7, 2010
• Results First Posted: February 5, 2018
• Last Update Posted: February 5, 2018
• Sponsor: Boston Children's Hospital
• Information provided by (Responsible Party): Andrew Eric Radbill, Boston Children's Hospital

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Pediatrics; Defibrillators, Implantable	Diagnostic Test: Defibrillator threshold testing; Other: Observation of post-shock intrinsic cardiac rhythm

Study Design

• Study Type: Observational
• Actual Enrollment: 20 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Defibrillation Thresholds in a Pediatric Cohort Using Binary Search Protocol
• Actual Study Start Date: June 4, 2009
• Actual Primary Completion Date: May 26, 2010
• Actual Study Completion Date: May 10, 2012

Groups and Cohorts

Group/Cohort

Intervention/treatment

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).

Diagnostic Test: Defibrillator threshold testing; 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.; Other: Observation of post-shock intrinsic cardiac rhythm; 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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Do DFTs Vary by Type of ICD Systems Implanted? [ Time Frame: During clinical ICD procedure, as a single event ]
   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).
2. Intrinsic Heart Rate in the Immediate Post-defibrillation Period [ Time Frame: During clinical ICD procedure, as a single event ]
   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.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

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

Criteria

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

Contacts and Locations

Locations

United States, Massachusetts

Children's Hospital Boston

Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Boston Children's Hospital

Investigators

• Principal Investigator: Andrew E Radbill, MD; Boston Children's Hospital

More Information

• Responsible Party: Andrew Eric Radbill, Assistant Professor of Pediatrics, Boston Children's Hospital
• ClinicalTrials.gov Identifier: NCT01043562
• Other Study ID Numbers: 09-04-0209
• First Posted: January 7, 2010
• Results First Posted: February 5, 2018
• Last Update Posted: February 5, 2018
• Last Verified: July 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No