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

Completed

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

In brief

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.

Key facts

Study ID

NCT01605500

Run by

Englewood Hospital and Medical Center

People needed

100

Starts

2012-06-01

Expected to finish

2015-06-01

Last updated by the study team

2016-02-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Known deafness
• Recent (fewer than 6 weeks) ICD pocket surgery
• Non-Generation 2 Medtronic ICD
• Pocket hematoma
• Pocket infection

Where it is running

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

Full record on ClinicalTrials.gov

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