ICD MalfunctionNCT05713708
S-ICD Electrode Registry
An observational study of ICD Malfunction and Sudden Cardiac Death, run by Universitätsklinikum Köln at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- ICD Malfunction, Sudden Cardiac Death
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2023to 3 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients who received an S-ICD at the participating sites for whom meaningful follow-up data is available will be included.
Who may be able to join
- status post S-ICD insertion
Who cannot join
- no available follow-up data beyond 2 weeks after insertion
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Cologne
Cologne, North Rhine-Westphalia, 50937
Jakob Luker, MD, +4922147832396, jakob.lueker@Uk-Koln.de
About this study
Official title: Multicenter Registry for S-ICD Electrodes
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.
Read the 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
- Keywords
- subcutaneous cardioverter-defibrillator, S-ICD, electrode malfunction, lead failure, battery depletion
- Medical subject headings
- Death, Sudden, Cardiac
What is being measured
The primary outcome is the main question the study is designed to answer.
Sense B Electrode Failure
Incidence of the Sense B Electrode Failure of the S-ICD Lead.
Measured: 3 months to 70 months after device insertion
Secondary outcomes (1)
Premature Battery Depletion
Incidence of battery depletion of the S-ICD generator after insertion.
Measured: 3 months to 70 months after device insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion3 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ICD MalfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Köln
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05713708
- Sponsor's protocol ID
- SICDLEAD
- Status last verified
- Oct 2023
- First submitted
- 27 Jan 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36652082Haeberlin 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.
PubMed 36353759Wormann 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.
PubMed 38885309Wormann 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.
PubMed 38861398
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Registry for S-ICD Electrodes
- ClinicalTrials.gov ID
- NCT05713708
- Acronym / sponsor ID
- SICDLEAD
- Conditions
- ICD Malfunction, Sudden Cardiac Death
- Keywords
- subcutaneous cardioverter-defibrillator, S-ICD, electrode malfunction, lead failure, battery depletion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Universitätsklinikum KölnUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 3 Nov 2024 (estimated)
- First posted
- 6 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who received an S-ICD at the participating sites for whom meaningful follow-up data is available will be included.
Key inclusion criteria (1 listed)
- status post S-ICD insertion
Key exclusion criteria (1 listed)
- no available follow-up data beyond 2 weeks after insertion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sense B Electrode Failure
Time frame: 3 months to 70 months after device insertion
Incidence of the Sense B Electrode Failure of the S-ICD Lead.
1 secondary outcome
Premature Battery Depletion
Time frame: 3 months to 70 months after device insertion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Background: PubMed 36652082Luker 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.
- Background: PubMed 36353759Haeberlin 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.
- Derived from this study: PubMed 38885309Wormann 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.
- Derived from this study: PubMed 38861398Wormann 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ICD Malfunction and Sudden Cardiac Death, run by Universitätsklinikum Köln at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jakob Lüker, MD (+4922147832396, jakob.lueker@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sense B Electrode Failure (time frame: 3 months to 70 months after device insertion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05713708, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2023.