iPod and Other MP3 Players on ICDs and Pacemakers in Children

NCT00542854 | Completed

• 1 other identifier: CHB-07-08-0308
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Block; Bradycardia; Tachycardia; Arrhythmia

Keywords

arrhythmia; pacemaker; defibrillator; electromagnetic interference

Outcome Measures

Primary Outcomes (1)

• Change in pacemaker sensing thresholds, pacing thresholds, telemetry interference or pacemaker inhibition.

  10 minutes

Study Arms (1)

MP3

4 different brands of MP3 players will be tested at 3 distances from pacemakers and ICDs.

Device: MP3

Interventions

MP3 DEVICE

4 different brands of MP3 players will be tested at 3 distances from ICD/pacemaker site in children and adults with congenital heart disease.

MP3

Eligibility Criteria

• Age: 4 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Age less than 4 or inability to communicate adequately with study team

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Heart Block; Bradycardia; Tachycardia; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Charles Berul, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 10, 2007
• First Posted: October 12, 2007
• Study Start: October 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: January 28, 2009

Record last verified: 2009-01

Locations

US (1)