An observational study in ICD Malfunction and Sudden Cardiac Death, sponsored by Universitätsklinikum Köln. Not yet recruiting at 1 site in Germany. Open to participants aged 8 Years and older. Per ClinicalTrials.gov, last updated 2023-10-13.
Sponsored by Universitätsklinikum Köln · Observational
Among 43 studies in Death, Sudden, Cardiac with a site in Germany — 6 open to participants now, 7 under way, none of them phase 3. Death, Sudden, Cardiac · Germany.
Among the 43 studies in Death, Sudden, Cardiac with a site in Germany, this one is the 8th largest by planned enrollment of the 24 observational ones that give a count, is one of 2 that started in 2023, is one of 24 observational ones, and was the 41st registered.
363 studies on the registry are indexed under Death, Sudden, Cardiac; 84 are open to participants now.
Browse Death, Sudden, Cardiac studies →6 of the 43 studies in Death, Sudden, Cardiac with a site in Germany are open now. Recruiting first, the newest first:
Universitätsklinikum Köln · Sites in Germany
Charite University, Berlin, Germany · Sites in Germany, Austria, Belgium and 10 more countries
University of Luebeck · Sites in Germany
Western Sydney Local Health District · Sites in Germany, United States, Australia and 12 more countries
Klinik für Kardiologie, Pneumologie und Angiologie · Sites in Germany
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 63 Death, Sudden, Cardiac studies recruiting now, 41 (65%) set no upper age limit and 11 (17%) stop at 75 or younger; 21 take children under 18; 7 take healthy volunteers.
This study: 8 Years and older · all sexes · no healthy volunteers.
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43 studies; the count open now beside each. This study's row is marked.
First in 1993; this study’s year is marked. 2 started in 2023.
This study's planned enrollment of 1,000 is above the median of 449 across 202 observational studies indexed under Death, Sudden, Cardiac.
Median enrollment 180 across the 18 interventional studies, 410 across the 24 observational. Of the 27 that completed or were terminated, 4 (15%) have results posted.
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10 of 43 have an industry lead sponsor. The 10 most frequent:
Universitätsklinikum Köln is the lead sponsor of 33 studies on the registry; 5 are open to participants now.
Universitätsklinikum Köln has 2 studies filed under Death, Sudden, Cardiac — fewer than ten, so there is no comparison to draw.
1 of the studies in Death, Sudden, Cardiac with a site in Germany that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05665608Charite University, Berlin, GermanyPrevention Of Sudden Cardiac Death After Myocardial Infarction by Defibrillator Implantation | 2027-11-30 |
Among the 43 studies in Death, Sudden, Cardiac with a site in Germany, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
All patients who received an S-ICD at the participating sites for whom meaningful follow-up data is available will be included.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Sense B Electrode Failure
Incidence of the Sense B Electrode Failure of the S-ICD Lead.
Time frame: 3 months to 70 months after device insertion
Premature Battery Depletion
Incidence of battery depletion of the S-ICD generator after insertion.
Time frame: 3 months to 70 months after device insertion
Plan to share: No
Start is estimated for Nov 2023; primary completion for Nov 2024, 12 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Universitätsklinikum Köln