Ultrasound guidance for S‑ICD implantation
Feasibility of an Intra-operative and Non-fluoroscopic Subcutaneous ICD Positioning and Assessment of the PRAETORIAN Score During Implantation: a Pilot Study
This pilot will test whether ultrasound can replace pre‑operative X‑ray and allow intraoperative estimation of the PRAETORIAN score for patients receiving a subcutaneous ICD.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Sex | All |
| Sponsor | Universitätsklinikum Köln Academic / other |
| Locations | 2 sites (Cologne, North Rhine-Westphalia and 1 other locations) |
| Trial ID | NCT06771700 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults scheduled for S‑ICD implantation at the center who can provide informed consent and are not pregnant.
Not a fit: Patients who require transvenous ICDs, are pregnant, cannot consent, or whose chest anatomy prevents reliable ultrasound imaging may not benefit.
Why it matters
Potential benefit: If successful, this approach could let teams use ultrasound instead of pre‑operative X‑ray and estimate the PRAETORIAN score during surgery, reducing radiation exposure and enabling earlier risk stratification.
How similar studies have performed: The PRAETORIAN score is validated on post‑operative chest X‑rays to predict defibrillation success, but using intraoperative ultrasound to determine the score is novel with limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * consecutive patients presenting for S-ICD implantation at our institution Exclusion Criteria: * patients unable to consent. * pregnancy
Where this trial is running
Cologne, North Rhine-Westphalia and 1 other locations
- University Hospital Cologne — Cologne, North Rhine-Westphalia, Germany (Not_yet_recruiting)
- University Hospital Cologne — Cologne, Germany (Recruiting)
Study contacts
- Study coordinator: Jakob Luker, MD
- Email: jakob.luker@uk-koeln.de
- Phone: +4947832396
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.