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

This study is currently recruiting participants.
Verified January 2013 by Englewood Hospital and Medical Center
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Englewood Hospital and Medical Center
ClinicalTrials.gov Identifier:
NCT01605500
First received: May 18, 2012
Last updated: January 17, 2013
Last verified: January 2013
History of Changes
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Investigation of the Utility of the Audible Alert in Current Generation Medtronic ICDs

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Englewood Hospital and Medical Center:

Primary Outcome Measures:
  • Audibility [ Time Frame: participants will be tested during a single, routine clinic visit - the average duration for each patient will be 30 minutes ] [ Designated as safety issue: No ]
    how frequently patients are able to detect the alert tones


Secondary Outcome Measures:
  • Loudness value [ Time Frame: 1 month ] [ Designated as safety issue: No ]

    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



Estimated Enrollment: 200
Study Start Date: June 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Medtronic ICDs
Patients with Generation 2 Medtronic ICDs

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01605500

Contacts
Contact: Grant Simons, MD 201-894-3533 grant.simons@ehmc.com
Contact: Meryna Manandhar 201-894-3907 meryna.manandhar@ehmc.com

Locations
United States, New Jersey
Englewood Hospital and Medical Center Recruiting
Englewood, New Jersey, United States, 07631
Contact: Grant Simons, MD     201-894-3533     grant.simons@ehmc.com    
Contact: Meryna Manandhar     201-894-3907     meryna.manandhar@ehmc.com    
Principal Investigator: Grant Simons, MD            
Sub-Investigator: David Feigenblum, MD            
Sub-Investigator: Dmitry Nemirovsky, MD            
Sponsors and Collaborators
Englewood Hospital and Medical Center
Medtronic
Investigators
Principal Investigator: Grant Simons, MD Englewood Hospital and Medical Center
  More Information

Additional Information:
Site information  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Englewood Hospital and Medical Center
ClinicalTrials.gov Identifier: NCT01605500     History of Changes
Other Study ID Numbers: E-12-445
Study First Received: May 18, 2012
Last Updated: January 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Englewood Hospital and Medical Center:
ICD

ClinicalTrials.gov processed this record on May 16, 2013