Clinical trial NCT01605500: Utility of the Audible Alert in Current Generation Medtronic Implantable Cardioverter-defibrillators
Official title: Investigation of the Utility of the Audible Alert in Current Generation Medtronic ICDs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients With a Generation 2 Medtronic Implantable Cardioverter-defibrillator(ICD)
Keywords: ICD
Lead sponsor: Englewood Hospital and Medical Center
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2012-05-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who have a Generation 2 Medtronic implantable cardioverter-defibrillator (ICD)

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Audibility
timeFrame: participants will be tested during a single, routine clinic visit - the average duration for each patient will be 30 minutes
Secondary outcomes:
measure: Loudness value
timeFrame: 1 month
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Englewood Hospital and Medical Center
state: New Jersey
Study officials:
affiliation: Englewood Hospital and Medical Center
name: Grant Simons, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Simons EC, Feigenblum DY, Nemirovsky D, Simons GR. Alert tones are frequently inaudible among patients with implantable cardioverter-defibrillators. Pacing Clin Electrophysiol. 2009 Oct;32(10):1272-5. doi: 10.1111/j.1540-8159.2009.02480.x. Epub 2009 Aug 18.