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Study identifier: NCT06771700 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

S-ICD Implantation: US Based Pilot Study

Condition: Sudden Cardiac Death  ·  Sponsor: Universitätsklinikum Köln

PhaseNA
Planned participants20
Who can joinAll sexes, N/A to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Jakob Luker, MD  ·  +4947832396  ·  jakob.luker@uk-koeln.de

Jonas Worman, MD  ·  +4947832396  ·  jonas.worman@uk-koeln.de

Always discuss trial participation with your own doctor first.

Locations (2)

University Hospital CologneCologne, North Rhine-Westphalia, GermanyNot Yet Recruiting
University Hospital CologneCologne, GermanyRecruiting

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Source record: clinicaltrials.gov/study/NCT06771700