Englewood Hospital and Medical Center
Englewood, New Jersey, 07631, United States
Completed
NCT Number: NCT01605500
Utility of the Audible Alert in Current Generation Medtronic Implantable Cardioverter-defibrillators
The purpose of this study is to determine whether the alert tones emitted by the latest generation of Medtronic implantable cardioverter-defibrillators (ICDs) are audible to patients.
ICD patients can have difficulties hearing the beeps, which are designed to notify patients of possible lead or generator malfunction. In fact, the only published study of this issue, conducted at Englewood Hospital and Medical Center, revealed that only 50% of patients with older Medtronic devices were able to hear alerts. Since then, modifications to the alert have been made by Medtronic. This study will establish the "real-world" value of these changes and also provide useful in vivo information regarding the validity of the in vitro techniques which have been used thus far to design the Patient Alert feature.
Completed
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Notify MeKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
There will be a single study visit. In a quiet examination room, the Patient Alert tones will be demonstrated to the subjects. Subsequently, this will be repeated with a wall air conditioner turned on. The subjects will then be asked to complete a three-part questionnaire regarding their perceptions of the Patient Alert tones.
Data analysis will include overall ability to hear tones, as well as subgroup analysis according to gender, age, and BMI.
Simultaneously, in order to calculate the loudness of the alert tones, digital recordings will be obtained using two microphones located near the subject. These digital recordings will be analyzed, and a loudness value will be calculated. The loudness value is a calculated index, devised by Medtronic, which incorporates frequency and intensity. Data analysis will include a correlation between loudness value and patient characteristics, and between loudness value and ability of subjects to perceive the tones.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Previous insertion of a Medtronic Generation 2 ICD (Consulta, Secura, Concerto II, Virtuoso II, Maximo II devices) not fewer than 7 days prior to study entry
- Able to provide informed consent
Exclusion criteria
- Known deafness
- Recent (fewer than 6 weeks) ICD pocket surgery
- Non-Generation 2 Medtronic ICD
- Pocket hematoma
- Pocket infection
Treatment and study plan
Primary outcomes
-
Audibility
Time frame: participants will be tested during a single, routine clinic visit - the average duration for each patient will be 30 minutes
how frequently patients are able to detect the alert tones
Secondary outcomes
-
Loudness value
Time frame: 1 month
digital recordings of the tones will be analyzed to determine the loudness value
loudness value is a calculated index, devised by Medtronic, which incorporates frequency and intensity
Sponsors and collaborators
Lead sponsor
Englewood Hospital and Medical Center
Other
Collaborators
- Medtronic
Registry information
Official study title
Investigation of the Utility of the Audible Alert in Current Generation Medtronic ICDs
Important dates
- Study start
- 2012
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- May 25, 2012
- Registry last updated
- Feb 19, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.