Intra-operative Assessment of the PRAETORIAN Score During S-ICD Implantation
Launched by UNIVERSITÄTSKLINIKUM KÖLN · Jan 7, 2025
Trial Information
Current as of June 27, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial, called the PRAETORIAN study, is looking at a new way to predict how successful a certain heart device, called a subcutaneous implantable cardioverter-defibrillator (S-ICD), will be in stopping dangerous heart rhythms. The PRAETORIAN score is a tool that can help doctors know if the device will work well, but it is usually calculated after the surgery. This study aims to see if doctors can calculate this score during the surgery itself. To do this, they will measure the distance between the lead (a small wire inside the device) and the chest bone, as well as the position of the device.
The study will include ten patients who are scheduled to have an S-ICD implanted at the hospital. To be eligible, patients must be receiving this procedure and should be able to give their consent. Unfortunately, pregnant women and those unable to consent will not be included. Participants in this trial can expect to go through the standard surgery without any additional procedures, and the only follow-up required will be a regular chest X-ray on the first day after surgery. This study is not yet recruiting participants, but it aims to improve how doctors assess these heart devices during surgery.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • consecutive patients presenting for S-ICD implantation at our institution
- Exclusion Criteria:
- • patients unable to consent.
- • pregnancy
About Universitätsklinikum Köln
Universitätsklinikum Köln, located in Cologne, Germany, is a leading academic medical center renowned for its commitment to innovative research, high-quality patient care, and comprehensive medical education. As a prominent sponsor of clinical trials, the institution leverages its multidisciplinary expertise and state-of-the-art facilities to advance the understanding of various diseases and develop novel therapeutic approaches. With a focus on translational research, Universitätsklinikum Köln collaborates with national and international partners to enhance clinical outcomes and contribute to the global medical community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Cologne, Nrw, Germany
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported