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Sponsored by: |
Children's Hospital Boston |
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Information provided by: | Children's Hospital Boston |
ClinicalTrials.gov Identifier: | NCT00542854 |
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 |
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Heart Block Bradycardia Tachycardia Arrhythmia |
Device: MP3 |
Study Type: | Observational |
Study Design: | Case-Crossover, 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 |
Estimated Enrollment: | 100 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | September 2008 |
Groups/Cohorts | Assigned Interventions |
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MP3
4 different brands of MP3 players will be tested at 3 distances from pacemakers and ICDs.
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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.
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Ages Eligible for Study: | 4 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Children and adults with congenital heart disease who have an implanted pacemaker or defibrillator
Inclusion Criteria:
Exclusion Criteria:
Contact: Charles Berul, MD | 617-355-6432 | charles.berul@cardio.chboston.org |
United States, Massachusetts | |
Children's Hospital Boston | Recruiting |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Charles Berul, MD | Children's Hospital Boston |
Study ID Numbers: | CHB-07-08-0308 |
Study First Received: | October 10, 2007 |
Last Updated: | October 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00542854 |
Health Authority: | United States: Institutional Review Board |
arrhythmia pacemaker defibrillator electromagnetic interference |
Heart Diseases Heart Block Tachycardia Bradycardia Arrhythmias, Cardiac |
Pathologic Processes Cardiovascular Diseases |