Cardiac Arrest Clinical Trials

Find Cardiac Arrest Clinical Trials Near You

Feasibility of an Intra-operative and Non-fluoroscopic Subcutaneous ICD Positioning and Assessment of the PRAETORIAN Score During Implantation: a Pilot Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• consecutive patients presenting for S-ICD implantation at our institution

Locations
Other Locations
Germany
University Hospital Cologne
RECRUITING
Cologne
University Hospital Cologne
NOT_YET_RECRUITING
Cologne
Contact Information
Primary
Jakob Luker, MD
jakob.luker@uk-koeln.de
+4947832396
Backup
Jonas Worman, MD
jonas.worman@uk-koeln.de
+4947832396
Time Frame
Start Date: 2025-03-01
Estimated Completion Date: 2025-11-01
Participants
Target number of participants: 20
Treatments
Experimental: S-ICD Implantation
Patients are implanted with an S-ICD according to standard clinical practice. 1) The ideal lead and device position are determined using the new US method. Any deviation by more than 0.5 cm is counted as a significant deviation. 2) The intraoperative PRAETORIAN Score is calculated based on additional intraoperative measurements.
Related Therapeutic Areas
Sponsors
Leads: Universitätsklinikum Köln

This content was sourced from clinicaltrials.gov