Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Consecutive patients presenting for S-ICD implantation at the study institution
You will not qualify if you...
- Patients unable to consent
- Pregnancy
AI-Screening
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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
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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