Utility of the Audible Alert in Current Generation Medtronic Implantable Cardioverter-defibrillators

Completed

• Conditions: Patients With a Generation 2 Medtronic Implantable Cardioverter-defibrillator(ICD)

• Registration Number: NCT01605500
• Lead Sponsor: Englewood Hospital and Medical Center

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.

Study Timeline

• Study First Submitted: 2012-05-18
• Study First Submitted QC: 2012-05-21
• Study First Posted: 2012-05-25
• Study Start: 2012-06
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-18
• Last Update Posted: 2016-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Audibility	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 Outcome Measures

Name	Time	Method
Loudness value	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

Trial Locations

Locations (1)

Englewood Hospital and Medical Center; 🇺🇸 Englewood, New Jersey, United States