NCT06771700 S-ICD Implantation: US Based Pilot Study
| NCT ID | NCT06771700 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitätsklinikum Köln |
| Condition | Sudden Cardiac Death |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2025-10-30 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * consecutive patients presenting for S-ICD implantation at our institution Exclusion Criteria: * patients unable to consent. * pregnancy