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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

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

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

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
04

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

05

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

06

Study locations

1 of 1 sites recruiting
  • University Hospital Cologne
    Cologne, 50937, Germany
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

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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