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NCT06388382 Clinical Trial

Investigation of the Audible ICD Alert Tone

Implantable Defibrillator User Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06388382
Other study ID # UKKx2024
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 15, 2024
Est. completion date May 30, 2025

Study information
Verified date May 2024
Source Universitätsklinikum Köln
Contact Jakob Lueker
Phone +4922147832396
Email jakob.lueker@uk-koeln.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Ability of ICD patients to hear the audible ICD alert is being assessed.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 150
Est. completion date May 30, 2025
Est. primary completion date May 15, 2025
Accepts healthy volunteers No
Gender All
Age group 15 Years to 100 Years
Eligibility Inclusion Criteria: - patient equipped with a subcutaneous ICD - willing to participate Exclusion Criteria: - S-ICD implantation within the past 3 weeks - patient is deaf

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Alert tone demonstration
Patients are demonstrated the alert tone of their ICD

Locations
Country Name City State
Germany University Hospital Cologne Cologne

Sponsors (1)
Lead Sponsor Collaborator
Universitätsklinikum Köln

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Alert tone audible Patients state if they hear or don't hear the alert tone 1 minute after demonstration
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