Ultrasound guidance for S‑ICD implantation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot enrolls about 20 consecutive patients scheduled for subcutaneous ICD (S‑ICD) implantation at University Hospital Cologne. During implantation, clinicians will use ultrasound with a dummy electrode and device on the chest to choose lead and generator positions, and then confirm positioning with the current standard fluoroscopic X‑ray before implanting. The study will also test whether manual intraoperative measurements of lead‑to‑sternum distance and generator position by non‑fluoroscopic means allow calculation of the PRAETORIAN score prior to defibrillation testing. There are no deviations from standard implantation procedures and no additional follow‑up beyond the routine post‑operative chest X‑ray on day one.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* consecutive patients presenting for S-ICD implantation at our institution

Exclusion Criteria:

* patients unable to consent.
* pregnancy

Where it's running

• University Hospital Cologne
  Cologne, Germany Recruiting
• University Hospital Cologne
  Cologne, North Rhine-Westphalia, Germany Not yet recruiting

Study contacts

• Study coordinator: Jakob Luker, MD
• Email: jakob.luker@uk-koeln.de
• Phone: +4947832396

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.