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

February 18, 2016 updated by: Englewood Hospital and Medical Center

Investigation of the Utility of the Audible Alert in Current Generation Medtronic ICDs

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Englewood, New Jersey, United States, 07631
        • Englewood Hospital and Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients who have a Generation 2 Medtronic implantable cardioverter-defibrillator (ICD)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Medtronic ICDs
Patients with Generation 2 Medtronic ICDs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
participants will be tested during a single, routine clinic visit - the average duration for each patient will be 30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Englewood Hospital and Medical Center

Collaborators

Medtronic

Investigators

  • Principal Investigator: Grant Simons, MD, Englewood Hospital and Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

May 18, 2012

First Submitted That Met QC Criteria

May 21, 2012

First Posted (ESTIMATE)

May 25, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

February 19, 2016

Last Update Submitted That Met QC Criteria

February 18, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • E-12-445

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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