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NCT04858672: Surge-ICD
Shock Testing to Unmask RV Lead and GEnerator Malfunction in ICD Patients: the SURGE-ICD Registry
trial in Implantable Defibrillator Lead Dysfunction in 300 participants. Status unknown.
15 June 2025
Quick facts
| Lead sponsor | Universitätsklinikum Köln |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 300 |
| Start date | 23 March 2022 |
| Primary completion | 15 June 2025 |
| Estimated completion | 15 June 2025 |
| Sites | 1 location across Germany |
Conditions studied
- Implantable Defibrillator Lead Dysfunction — all drugs for Implantable Defibrillator Lead Dysfunction →
- Implantable Automatic Defibrillator Malfunction — all drugs for Implantable Automatic Defibrillator Malfunction →
- Implantable Defibrillator User — all drugs for Implantable Defibrillator User →
Sponsor
Universitätsklinikum Köln — full company profile →
Who can join
18 and older, any sex, with Implantable Defibrillator Lead Dysfunction or Implantable Automatic Defibrillator Malfunction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Shock testing during ICD generator replacement has been omitted by many centers. A previous study revealed lead failures in internally cardioverted patients with previously normal HV-lead values. The real prevalence of unrecognized "silent" lead failure in ICD patients remains unknown. As a consequence, patients may be equipped with an ICD which is unable to provide life-saving shocks. The proposed registry aims to include patients presenting for ICD generator replacement or electrical cardioversion of atrial arrhythmia. The protocol mandates either a commanded synchronized high energy shock prior to generator replacement or internal cardioversion of atrial arrhythmia to provoke the unmasking of silent lead failure.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04858672
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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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 NCT04858672 (US National Library of Medicine, public domain)
- 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: 2 June 2022
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/NCT04858672.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing