Assessing if patients can hear the alert tone from their implantable defibrillator
Investigation of the Audible Alert Tone in ICD Patients with Subcutaneous Cardioverter Defibrillators
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 |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 15 Years to 100 Years |
| Sex | All |
| Sponsor | Universitätsklinikum Köln Academic / other |
| Locations | 1 site (Cologne) |
| Trial ID | NCT06388382 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are patients who have a subcutaneous ICD and are willing to participate.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Cologne
- University Hospital Cologne — Cologne, Germany (Recruiting)
Study contacts
- Study coordinator: Jakob Lueker
- Email: jakob.lueker@uk-koeln.de
- Phone: +4922147832396
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.