Precise Measurement of Pediatric Defibrillation Thresholds

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Children's Hospital Boston.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01043562
First received: January 6, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

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
Pediatrics
Defibrillators, Implantable

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Defibrillation Thresholds in a Pediatric Cohort Using Binary Search Protocol

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Defibrillation threshold as measured by the binary search protocol [ Time Frame: During clinical ICD procedure, as a single event ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Do DFTs vary amongst pediatric patients who have had different types of ICD systems implanted? [ Time Frame: During clinical ICD procedure, as a single event ] [ Designated as safety issue: No ]
  • How often do these pediatric patients have intrinsic slow heart rate and default to pacing in the immediate post-defibrillation period? [ Time Frame: During clinical ICD procedure, as a single event ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: June 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pediatric ICD pts

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01043562

Locations
United States, Massachusetts
Children's Hospital Boston Recruiting
Boston, Massachusetts, United States, 02115
Contact: Andrew E Radbill, MD    617-355-7893    andrew.radbill@cardio.chboston.org   
Principal Investigator: Andrew E Radbill, MD         
Sponsors and Collaborators
Children's Hospital Boston
Investigators
Principal Investigator: Andrew E Radbill, MD Children's Hospital Boston
  More Information

No publications provided

Responsible Party: Andrew Radbill, MD, Department of Cardiology
ClinicalTrials.gov Identifier: NCT01043562     History of Changes
Other Study ID Numbers: 09-04-0209
Study First Received: January 6, 2010
Last Updated: January 6, 2010
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 20, 2014