S-ICD Implantation: US Based Pilot Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversitätsklinikum Köln

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

consecutive patients presenting for S-ICD implantation at our institution

Disqualifiers

patients unable to consent.

pregnancy

Trial design

Design model

Single group

Treatments tested in this trial

  • Intraoperative PRAETORIAN Score

    Diagnostic test

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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: S-ICD ImplantationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

PRAETORIAN

The intraoperative PRAETORIAN Score is correlated with the regular PRAETORIAN Score

Time frame
1 day after the device implantation, when chest x-ray is available

Secondary outcomes

Other outcomes

Sponsors and contacts

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