S-ICD Electrode Registry

NCT ID: NCT05713708

Last Updated: 2023-10-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2024-11-03

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.

Detailed Description

The S-ICD therapy is an established treatment for primary and secondary prevention of sudden cardiac death. Recently, a report was published about a previously described complication of the electrode, in which a defect of the so-called Sense-B component is reported in a few affected patients. The defect of this component of the electrode leads to electrode noise and subsequent inadequate shocks. The cause of the defect and the incidence are currently unknown. The manufacturer Boston Scientific has issued a warning and advisory.

In addition to this advisory regarding the electrode of the S-ICD, there is also an active warning from the manufacturer regarding the possible premature exhaustion of the S-ICD battery. This is caused by an error in the manufacturing process of approximately 40,000 devices produced in 2018. The manufacturer estimates the incidence of premature battery exhaustion to be 4-15% within 5 years. Independent data on the incidence of premature exhaustion of these devices were initially scarce. The investigators conducted a retrospective data query in 2021 to capture the incidence of battery exhaustion at that time. The incidence was 3.7% after 5 years. The average follow-up time was only 3 years. The incidence of premature exhaustion increased significantly after 3 years, so data with a longer follow-up period is urgently needed.

Given that these data already show that the incidence of premature exhaustion increases significantly after 3 years and the observation period in the retrospective data was on average slightly under 3 years, a further query of the existing clinical data on the battery as part of this register is also planned. This would allow for a more accurate estimate of the risk of premature battery depletion.

Conditions

ICD Malfunction; Sudden Cardiac Death

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• status post S-ICD insertion

Exclusion Criteria

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

• Minimum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsklinikum Köln

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital Cologne

Cologne, North Rhine-Westphalia, Germany

Countries

Germany

Central Contacts

Jakob Lüker, MD

Role: CONTACT

jakob.lueker@uk-koeln.de

+4922147832396

Facility Contacts

Jakob Luker, MD

Role: primary

jakob.lueker@Uk-Koln.de

+4922147832396

References

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.

Reference Type: BACKGROUND

PMID: 36652082 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36353759 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38885309 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38861398 (View on PubMed)

Other Identifiers

SICDLEAD

Identifier Type: -

Identifier Source: org_study_id