S-ICD Implantation: US Based Pilot Study

Recruiting now · Not applicable

Conditions studied: Sudden Cardiac Death

In brief

This trial investigates two key aspects of the S-ICD implantation process. 1) For S-ICD implantation a pre-operative x-ray-based assessment of the anatomy and location of the heart is required. This study seeks to investigate the feasibility of US to potentially replace the need for x-ray 2) The PRAETORIAN score predicts defibrillation test success in subcutaneous ICD implantation but can only be calculated after the procedure. This pilot study aims to evaluate the feasibility of US determining the PRAETORIAN score intraoperatively. Lead-to-sternum distance and generator position measurments during the implantation procedure will be evaluated. Twenty consecutive patients scheduled for S-ICD implantation will be enrolled. The study involves no deviation from standard implantation procedures and requires no follow-up beyond standard post-operative chest X-ray on day one.

Key facts

Study ID

NCT06771700

Run by

Universitätsklinikum Köln

People needed

20

Starts

2025-03-01

Expected to finish

2025-11-01

Last updated by the study team

2025-07-09

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• patients unable to consent.
• pregnancy

Where it is running

• University Hospital Cologne — Cologne, Germany (enrolling)
• University Hospital Cologne — Cologne, North Rhine-Westphalia, Germany

Full record on ClinicalTrials.gov

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