Last reviewed · How we verify
NCT05713708
S-ICD Electrode Registry
trial in ICD Malfunction in 1,000 participants. Status unknown.
1 November 2024
Quick facts
| Lead sponsor | Universitätsklinikum Köln |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 1,000 |
| Start date | 1 November 2023 |
| Primary completion | 1 November 2024 |
| Estimated completion | 3 November 2024 |
| Sites | 1 location across Germany |
Conditions studied
- ICD Malfunction — all drugs for ICD Malfunction →
- Sudden Cardiac Death — all drugs for Sudden Cardiac Death →
Sponsor
Universitätsklinikum Köln — full company profile →
Who can join
8 and older, any sex, with ICD Malfunction or Sudden Cardiac Death. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Incidence, implications, and management of sense-B-noise failure in subcutaneous cardioverter-defibrillator patients: insights from a large multicentre registry.
Wörmann J, Strik M, Jurisic S, Stout K, et al · · 2024 · cited 1× · PMID 38861398 · DOI 10.1093/europace/euae161 -
Occurrence of premature battery depletion in a large multicentre registry of subcutaneous cardioverter-defibrillator patients.
Wörmann J, Strik M, Jurisic S, Stout K, et al · · 2024 · PMID 38885309 · DOI 10.1093/europace/euae170
Verify or expand the search:
- PubMed search for NCT05713708
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for ICD Malfunction
Currently open trials in the same condition.
- NCT04331249 — Perioperative Management Evaluation in Patients With CIED · recruiting
Other Universitätsklinikum Köln trials
Trials by the same sponsor.
- NCT06771700 — S-ICD Implantation: US Based Pilot Study · NA · recruiting
- NCT06388382 — Investigation of the Audible ICD Alert Tone · recruiting
- NCT06063811 — Ventricular Tachycardia Ablation in LVAD Patients · unknown
- NCT05389241 — Laparoscopic Augmented Reality for Identification of Liver Lesions - a Pre-clinical Randomized Cross-over Trial · NA · unknown
- NCT04858672 — Shock Testing to Unmask RV Lead and GEnerator Malfunction in ICD Patients: the SURGE-ICD Registry · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05713708 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universitätsklinikum Köln
- Last refreshed: 13 October 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05713708.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing