iPod and Other MP3 Players on ICDs and Pacemakers in Children

This study has been completed.
Sponsor:
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00542854
First received: October 10, 2007
Last updated: January 27, 2009
Last verified: January 2009
  Purpose

Unlike phones, which are commonly held to the ear, music is now available via portable MP3 players and they can be held almost anywhere. Thaker et al state that Apple iPods cause pacemaker interference in 50% of their patients, with over-sensing in 20% of patients, telemetry interference in 29% of patients and pacemaker inhibition in 1.2% of patients. The mean age for their sample was 76.1 years +/- 8.6 years. We anticipate that a higher proportion of teenagers and children who have pacemakers use portable MP3 players than in the elderly adult population.We will include the first 100 patients with pacemakers and ICDs who consent for the prospective observational study a single tertiary care center. We intend to conduct a descriptive study, tabulating the number of times that a pacemaker or ICD has changes in the sensing thresholds, pacing thresholds, telemetry interference or pacemaker inhibition when exposed to a series of portable MP3 players at various distances. In addition, we will describe the nature and quantitative differences of those changes.


Condition Intervention
Heart Block
Bradycardia
Tachycardia
Arrhythmia
Device: MP3

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: A Pilot Study on the Effects of Digital Music Players on Implantable Cardioverter Defibrillators and Pacemakers in Pediatrics and Congenital Heart Disease

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change in pacemaker sensing thresholds, pacing thresholds, telemetry interference or pacemaker inhibition. [ Time Frame: 10 minutes ]

Estimated Enrollment: 100
Study Start Date: October 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
MP3
4 different brands of MP3 players will be tested at 3 distances from pacemakers and ICDs.
Device: MP3
4 different brands of MP3 players will be tested at 3 distances from ICD/pacemaker site in children and adults with congenital heart disease.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   4 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Children and adults with congenital heart disease who have an implanted pacemaker or defibrillator

Criteria

Inclusion Criteria:

  • Children and adults with congenital heart disease who have an implanted pacemaker or defibrillator

Exclusion Criteria:

  • Age less than 4 or inability to communicate adequately with study team
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00542854

Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Children's Hospital Boston
Investigators
Principal Investigator: Charles Berul, MD Children's Hospital Boston
  More Information

No publications provided

Responsible Party: Charles Berul, MD - Principal Investigator, Children's Hospital Cardiology
ClinicalTrials.gov Identifier: NCT00542854     History of Changes
Other Study ID Numbers: CHB-07-08-0308
Study First Received: October 10, 2007
Last Updated: January 27, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
arrhythmia
pacemaker
defibrillator
electromagnetic interference

Additional relevant MeSH terms:
Bradycardia
Heart Block
Tachycardia
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 22, 2014