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

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ClinicalTrials.gov Identifier: NCT01605500
Recruitment Status : Completed
First Posted : May 25, 2012
Last Update Posted : February 19, 2016
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
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.


Condition or disease
Patients With a Generation 2 Medtronic Implantable Cardioverter-defibrillator(ICD)

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
Actual Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Investigation of the Utility of the Audible Alert in Current Generation Medtronic ICDs
Study Start Date : June 2012
Primary Completion Date : June 2015
Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Medtronic ICDs
Patients with Generation 2 Medtronic ICDs



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients who have a Generation 2 Medtronic implantable cardioverter-defibrillator (ICD)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01605500


Locations
United States, New Jersey
Englewood Hospital and Medical Center
Englewood, New Jersey, United States, 07631
Sponsors and Collaborators
Englewood Hospital and Medical Center
Medtronic
Investigators
Principal Investigator: Grant Simons, MD Englewood Hospital and Medical Center

Publications:
Responsible Party: Englewood Hospital and Medical Center
ClinicalTrials.gov Identifier: NCT01605500     History of Changes
Other Study ID Numbers: E-12-445
First Posted: May 25, 2012    Key Record Dates
Last Update Posted: February 19, 2016
Last Verified: February 2016

Keywords provided by Englewood Hospital and Medical Center:
ICD