Clinical Research Directory
Browse clinical research sites, groups, and studies.
S-ICD Implantation: US Based Pilot Study
Sponsor: Universitätsklinikum Köln
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.
Official title: Feasibility of an Intra-operative and Non-fluoroscopic Subcutaneous ICD Positioning and Assessment of the PRAETORIAN Score During Implantation: a Pilot Study
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2025-03-01
Completion Date
2025-11-01
Last Updated
2025-07-09
Healthy Volunteers
No
Conditions
Interventions
Intraoperative 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