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.
Patients With a Generation 2 Medtronic Implantable Cardioverter-defibrillator(ICD)
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Investigation of the Utility of the Audible Alert in Current Generation Medtronic ICDs|
- Audibility [ Time Frame: participants will be tested during a single, routine clinic visit - the average duration for each patient will be 30 minutes ] [ Designated as safety issue: No ]how frequently patients are able to detect the alert tones
- Loudness value [ Time Frame: 1 month ] [ Designated as safety issue: No ]
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
|Study Start Date:||June 2012|
|Study Completion Date:||June 2015|
|Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Patients with Generation 2 Medtronic ICDs
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01605500
|United States, New Jersey|
|Englewood Hospital and Medical Center|
|Englewood, New Jersey, United States, 07631|
|Principal Investigator:||Grant Simons, MD||Englewood Hospital and Medical Center|