Clinical trial Recruiting at 1 site Observational Ages 15 to 100

Assessing if patients can hear the alert tone from their implantable defibrillator

Official title: Investigation of the Audible Alert Tone in ICD Patients with Subcutaneous Cardioverter Defibrillators

Run by Universitätsklinikum Köln · NCT06388382 · Data updated 2026-11-12

This study is testing whether people with implantable defibrillators can hear the alert sounds from their devices to see if they are aware of potential heart issues.

More Implantable Defibrillator User trials

Quick facts

Study typeObservational
Ages15 Years to 100 Years
SexAll
Enrollment150 (estimated)
SponsorUniversitätsklinikum Köln
Academic / other
Locations1 site (Cologne)
StatusRecruiting
StartedOctober 1, 2024
Main results expectedMay 15, 2025
Study endsMay 30, 2025
Registry record updatedNovember 8, 2024
Trial IDNCT06388382 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are patients who have a subcutaneous ICD and are willing to participate.

Probably not a fit

Patients who have had an S-ICD implanted within the past 3 weeks or those who are deaf will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates the ability of patients with subcutaneous implantable cardioverter-defibrillators (ICDs) to hear the audible alert tone produced by their devices. Participants will be assessed for their awareness of the alert tone, which is crucial for timely response to potential cardiac events. The study aims to gather data on the effectiveness of the alert system in real-world settings. The findings could inform improvements in device design and patient education.

Why it matters

Potential benefit: If successful, this study could enhance patient safety by ensuring that ICD users are aware of alerts, leading to timely interventions during cardiac events.

How similar studies have gone: While there may be limited studies specifically focused on audible alert tones for ICDs, similar approaches in assessing device usability have shown promise in improving patient outcomes.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* patient equipped with a subcutaneous ICD
* willing to participate

Exclusion Criteria:

* S-ICD implantation within the past 3 weeks
* patient is deaf

Where it's running

  • University Hospital Cologne
    Cologne, Germany
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.