RecruitingNot ApplicableNCT06771700

S-ICD Implantation: US Based Pilot Study

Feasibility of an Intra-operative and Non-fluoroscopic Subcutaneous ICD Positioning and Assessment of the PRAETORIAN Score During Implantation: a Pilot Study


Sponsor

Universitätsklinikum Köln

Enrollment

20 participants

Start Date

Mar 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Inclusion Criteria1

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

Exclusion Criteria2

  • patients unable to consent.
  • pregnancy

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Interventions

DIAGNOSTIC_TESTIntraoperative PRAETORIAN Score

The intraoperative PRAETORIAN Score is calculated based on the additional measurements.


Locations(2)

University Hospital Cologne

Cologne, North Rhine-Westphalia, Germany

University Hospital Cologne

Cologne, Germany

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NCT06771700


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