Implantable Defibrillator UserNCT06388382
Investigation of the Audible ICD Alert Tone
An observational study of Implantable Defibrillator User, run by Universitätsklinikum Köln at 1 site in Germany.
Trial summary
Ability of ICD patients to hear the audible ICD alert is being assessed. Read more about this study
- Who is it for?
- Ages 15 to 100 years
- Conditions the study is for
- Implantable Defibrillator User
- What is being tested?
- Alert tone demonstration
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2024to 30 May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: S-ICD all comers
Who may be able to join
- patient equipped with a subcutaneous ICD
- willing to participate
Who cannot join
- S-ICD implantation within the past 3 weeks
- patient is deaf
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Cologne
Cologne, 50937
Jakob Lüker, MD, +4922147832396, jakob.lueker@uk-koeln.de
Jakob Lüker, MD
About this study
Official title: Investigation of the Audible Alert Tone in ICD Patients with Subcutaneous Cardioverter Defibrillators
Ability of ICD patients to hear the audible ICD alert is being assessed.
- Conditions
- Implantable Defibrillator User
- Being tested
- Alert tone demonstration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alert tone demonstrationOther
Patients are demonstrated the alert tone of their ICD
What is being measured
The primary outcome is the main question the study is designed to answer.
Alert tone audible
Patients state if they hear or don't hear the alert tone
Measured: 1 minute after demonstration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start1 Oct 2024
- Primary completion15 May 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implantable Defibrillator UserStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Köln
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06388382
- Sponsor's protocol ID
- UKKx2024
- Status last verified
- Nov 2024
- First submitted
- 23 Apr 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Audible Alert Tone in ICD Patients with Subcutaneous Cardioverter Defibrillators
- ClinicalTrials.gov ID
- NCT06388382
- Acronym / sponsor ID
- UKKx2024
- Conditions
- Implantable Defibrillator User
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universitätsklinikum KölnUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ability of ICD patients to hear the audible ICD alert is being assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- S-ICD all comers
Key inclusion criteria (2 listed)
- patient equipped with a subcutaneous ICD
- willing to participate
Key exclusion criteria (2 listed)
- S-ICD implantation within the past 3 weeks
- patient is deaf
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alert tone demonstrationPatients are demonstrated the alert tone of their ICD | Other | – |
Primary outcome
Alert tone audible
Time frame: 1 minute after demonstration
Patients state if they hear or don't hear the alert tone
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Implantable Defibrillator User, run by Universitätsklinikum Köln at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jakob Lueker (+4922147832396, jakob.lueker@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alert tone audible (time frame: 1 minute after demonstration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.