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

NCT01605500 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2016-02-19

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Englewood Hospital and Medical Center

    lead OTHER

Principal Investigators

  • Grant Simons, MD · Englewood Hospital and Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01605500 on ClinicalTrials.gov