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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 15 Years to 100 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Universitätsklinikum Köln Academic / other |
| Locations | 1 site (Cologne) |
| Status | Recruiting |
| Started | October 1, 2024 |
| Main results expected | May 15, 2025 |
| Study ends | May 30, 2025 |
| Registry record updated | November 8, 2024 |
| Trial ID | NCT06388382 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
- Study coordinator: Jakob Lueker
- Email: jakob.lueker@uk-koeln.de
- Phone: +4922147832396
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.