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RecruitingNCT06388382Updated Nov 8, 2024

Investigation of the Audible ICD Alert Tone

An observational study in Implantable Defibrillator User, sponsored by Universitätsklinikum Köln. Recruiting at 1 site in Germany. Open to participants aged 15 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-11-08.

Sponsored by Universitätsklinikum Köln · Observational

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 5 months ago, but the record still lists the study as recruiting.
  • Started Oct 2024; still recruiting 2 years 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
15 Years to 100 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Implantable Defibrillator User
03

In context

Lead sponsor

Universitätsklinikum Köln is the lead sponsor of 33 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

S-ICD all comers

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patient equipped with a subcutaneous ICD
  • willing to participate

Exclusion criteria

Exclusion Criteria:

  • S-ICD implantation within the past 3 weeks
  • patient is deaf
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Interventions

  • OtherAlert tone demonstration

    Patients are demonstrated the alert tone of their ICD

06

What researchers measure

Primary outcomes

  1. Alert tone audible

    Patients state if they hear or don't hear the alert tone

    Time frame: 1 minute after demonstration

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2024 (actual). Primary completion is estimated for May 2025, 7 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 23, 2024
First posted
Apr 29, 2024
StartActual
Oct 1, 2024
Primary completionEst.
May 15, 2025
CompletionEst.
May 30, 2025
Last update
Nov 8, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06388382
Lead sponsor
Universitätsklinikum Köln
Responsible party
Sponsor
First posted
Apr 29, 2024
Start date
Oct 1, 2024
Primary completion
May 15, 2025 (estimated)
Completion
May 30, 2025 (estimated)
Last update
Nov 8, 2024

Study contacts

Jakob Lueker
Contact
jakob.lueker@uk-koeln.de
+4922147832396

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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