Actively Recruiting

Phase Not Applicable
All Genders
NCT06771700

S-ICD Implantation: US Based Pilot Study

Led by Universitätsklinikum Köln · Updated on 2025-07-09

20

Participants Needed

2

Research Sites

35 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

S-ICD Implantation: US Based Pilot Study

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Consecutive patients presenting for S-ICD implantation at the study institution
Not Eligible

You will not qualify if you...

  • Patients unable to consent
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 2 locations

1

University Hospital Cologne

Cologne, North Rhine-Westphalia, Germany, 50937

Not Yet Recruiting

2

University Hospital Cologne

Cologne, Germany, 50823

Actively Recruiting

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Research Team

J

Jakob Luker, MD

CONTACT

J

Jonas Worman, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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