We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Medtronic ICDs
Patients with Generation 2 Medtronic ICDs


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Grant Simons, MD Englewood Hospital and Medical Center
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Englewood Hospital and Medical Center
ClinicalTrials.gov Identifier: NCT01605500    
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