NCT06388382

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 29, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
Last Updated

November 8, 2024

Status Verified

November 1, 2024

Enrollment Period

8 months

First QC Date

April 23, 2024

Last Update Submit

November 6, 2024

Conditions

Implantable Defibrillator User

Outcome Measures

Primary Outcomes (1)

  • Alert tone audible

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

    1 minute after demonstration

Interventions

Alert tone demonstrationOTHER

Patients are demonstrated the alert tone of their ICD

Eligibility Criteria

Age15 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

S-ICD all comers

You may qualify if:

  • patient equipped with a subcutaneous ICD
  • willing to participate

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Cologne

Cologne, 50937, Germany

RECRUITING

Central Study Contacts

Jakob Lueker

CONTACT

+4922147832396jakob.lueker@uk-koeln.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2024

First Posted

April 29, 2024

Study Start

October 1, 2024

Primary Completion

May 15, 2025

Study Completion

May 30, 2025

Last Updated

November 8, 2024

Record last verified: 2024-11

Locations

DE(1)