NCT05713708

Brief Summary

The subcutaneous implantable cardioverter defibrillator (S-ICD) is established in the prevention of sudden cardiac death, but recently a defect of the electrode's Sense-B component was reported in some patients. This lead to inadequate shocks due to noise. The cause and incidence of this defect are unknown. The manufacturer issued a warning regarding this defect and a possible premature depletion of the battery in some device. Independent data on the incidence of these issues is limited. Further data is needed to better understand the risk of these complications.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

January 27, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 6, 2023

Completed
9 months until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2024

Completed
Last Updated

October 13, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

January 27, 2023

Last Update Submit

October 11, 2023

Conditions

ICD MalfunctionSudden Cardiac Death

Keywords

subcutaneous cardioverter-defibrillatorS-ICDelectrode malfunctionlead failurebattery depletion

Outcome Measures

Primary Outcomes (1)

  • Sense B Electrode Failure

    Incidence of the Sense B Electrode Failure of the S-ICD Lead.

    3 months to 70 months after device insertion

Secondary Outcomes (1)

  • Premature Battery Depletion

    3 months to 70 months after device insertion

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients who received an S-ICD at the participating sites for whom meaningful follow-up data is available will be included.

You may qualify if:

  • \- status post S-ICD insertion

You may not qualify if:

  • \- no available follow-up data beyond 2 weeks after insertion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Related Publications (4)

  • Luker J, Strik M, Andrade JG, Raymond-Paquin A, Elrefai MH, Roberts PR, Perez OC, Kron J, Koneru J, Franqui-Rivera H, Sultan A, Ernst A, Schmitt J, Pott A, Veltmann C, Srinivasan NT, Collinson J, van Stipdonk AMW, Linz D, Fluschnik N, Tonnis T, Haeberlin A, Ploux S, Steven D. Incidence of premature battery depletion in subcutaneous cardioverter-defibrillator patients: insights from a multicenter registry. J Interv Card Electrophysiol. 2025 Oct;68(7):1409-1415. doi: 10.1007/s10840-023-01468-1. Epub 2023 Jan 18.

    PMID: 36652082BACKGROUND

  • Haeberlin A, Burri H, Schaer B, Koepfli P, Grebmer C, Breitenstein A, Reichlin T, Noti F. Sense-B-noise: an enigmatic cause for inappropriate shocks in subcutaneous implantable cardioverter defibrillators. Europace. 2023 Feb 16;25(2):767-774. doi: 10.1093/europace/euac202.

    PMID: 36353759BACKGROUND

  • Wormann J, Strik M, Jurisic S, Stout K, Elrefai M, Becher N, Schaer B, van Stipdonk A, Srinivasan NT, Ploux S, Breitenstein A, Kron J, Roberts PR, Toennis T, Linz D, Dulai R, Hermes-Laufer J, Koneru J, Erkuner O, Dittrich S, van den Bruck JH, Schipper JH, Sultan A, Rosenberger KD, Steven D, Luker J. Occurrence of premature battery depletion in a large multicentre registry of subcutaneous cardioverter-defibrillator patients. Europace. 2024 Jul 2;26(7):euae170. doi: 10.1093/europace/euae170.

    PMID: 38885309DERIVED

  • Wormann J, Strik M, Jurisic S, Stout K, Elrefai M, Becher N, Schaer B, van Stipdonk A, Srinivasan NT, Ploux S, Breitenstein A, Kron J, Roberts PR, Toennis T, Linz D, Dulai R, Hermes-Laufer J, Koneru J, Erkuner O, Dittrich S, van den Bruck JH, Schipper JH, Sultan A, Rosenberger KD, Steven D, Luker J. Incidence, implications, and management of sense-B-noise failure in subcutaneous cardioverter-defibrillator patients: insights from a large multicentre registry. Europace. 2024 Jun 3;26(6):euae161. doi: 10.1093/europace/euae161.

    PMID: 38861398DERIVED

MeSH Terms

Conditions

Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular DiseasesDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Jakob Lüker, MD

CONTACT

+4922147832396jakob.lueker@uk-koeln.de

Study Design

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

Study Record Dates

First Submitted

January 27, 2023

First Posted

February 6, 2023

Study Start

November 1, 2023

Primary Completion

November 1, 2024

Study Completion

November 3, 2024

Last Updated

October 13, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)