S-ICD Electrode Registry

Sudden Cardiac Death Clinical Trial

Official title:

Multicenter Registry for S-ICD Electrodes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05713708
• Other study ID #: SICDLEAD
• Status: Not yet recruiting
• Start date: November 1, 2023
• Est. completion date: November 3, 2024

Study information

• Verified date: October 2023
• Source: Universitätsklinikum Köln
• Contact: Jakob Lüker, MD
• Phone: +4922147832396
• Email: jakob.lueker[@]uk-koeln.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: November 3, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years and older

Eligibility

Inclusion Criteria:

• status post S-ICD insertion

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Death
• Death, Sudden, Cardiac
• ICD Malfunction
• Sudden Cardiac Death

Locations

Country	Name	City	State
Germany	University Hospital Cologne	Cologne	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Köln

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View Citation

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. 2023 Jan 18. doi: 10.1007/s10840-023-01468-1. Online ahead of print. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Premature Battery Depletion	Incidence of battery depletion of the S-ICD generator after insertion.	3 months to 70 months after device insertion