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

This study is currently recruiting participants.
Verified January 2014 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 16, 2014
Last verified: January 2014

May 18, 2012
January 16, 2014
June 2012
December 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01605500 on ClinicalTrials.gov Archive Site
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

Same as current
Not Provided
Not Provided
 
Utility of the Audible Alert in Current Generation Medtronic Implantable Cardioverter-defibrillators
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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Patients With a Generation 2 Medtronic Implantable Cardioverter-defibrillator(ICD)
Not Provided
Medtronic ICDs
Patients with Generation 2 Medtronic ICDs
Simons EC, Feigenblum DY, Nemirovsky D, Simons GR. Alert tones are frequently inaudible among patients with implantable cardioverter-defibrillators. Pacing Clin Electrophysiol. 2009 Oct;32(10):1272-5. Epub 2009 Aug 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
March 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Grant Simons, MD 201-894-3533 grant.simons@ehmc.com
Contact: Meryna Manandhar 201-894-3907 meryna.manandhar@ehmc.com
United States
 
NCT01605500
E-12-445
No
Englewood Hospital and Medical Center
Englewood Hospital and Medical Center
Medtronic
Principal Investigator: Grant Simons, MD Englewood Hospital and Medical Center
Englewood Hospital and Medical Center
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP