S-ICD Implantation: US Based Pilot Study

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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

Primary outcome measure(s)

• PRAETORIAN — 1 day after the device implantation, when chest x-ray is available
  The intraoperative PRAETORIAN Score is correlated with the regular PRAETORIAN Score

Trial sites (2)

More Universitätsklinikum Köln trials in Germany

Other trials for the same condition