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S-ICD Implantation: US Based Pilot Study

RecruitingNAAges any - anyAllUniversitätsklinikum Köln
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * consecutive patients presenting for S-ICD implantation at our institution Exclusion Criteria: * patients unable to consent. * pregnancy
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What it tests

  • Intraoperative PRAETORIAN Score
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Where

2 sites
University Hospital Cologne
Cologne, Germany
University Hospital Cologne
Cologne, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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