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iPod and Other MP3 Players on ICDs and Pacemakers in Children

This study has been completed.
Information provided by:
Boston Children’s Hospital Identifier:
First received: October 10, 2007
Last updated: January 27, 2009
Last verified: January 2009
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
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 Boston Children’s Hospital:

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
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


Ages Eligible for Study:   4 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children and adults with congenital heart disease who have an implanted pacemaker or defibrillator

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
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 identifier: NCT00542854

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

Responsible Party: Charles Berul, MD - Principal Investigator, Children's Hospital Cardiology Identifier: NCT00542854     History of Changes
Other Study ID Numbers: CHB-07-08-0308
Study First Received: October 10, 2007
Last Updated: January 27, 2009

Keywords provided by Boston Children’s Hospital:
electromagnetic interference

Additional relevant MeSH terms:
Heart Block
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes processed this record on May 25, 2017