An interventional study of Intraoperative PRAETORIAN Score in Sudden Cardiac Death, sponsored by Universitätsklinikum Köln. Recruiting at 2 sites in Germany. Per ClinicalTrials.gov, last updated 2025-07-09.
Sponsored by Universitätsklinikum Köln · Not applicable, Interventional, and Other
Among 43 studies in Death, Sudden, Cardiac with a site in Germany — 6 open to participants now, 7 under way, none of them phase 3. Death, Sudden, Cardiac · Germany.
Among the 43 studies in Death, Sudden, Cardiac with a site in Germany, this one is the 17th largest by planned enrollment of the 18 interventional ones that give a count, is the only one that started in 2025, is one of 13 with no phase, and was the 42nd registered.
363 studies on the registry are indexed under Death, Sudden, Cardiac; 84 are open to participants now.
Browse Death, Sudden, Cardiac studies →6 of the 43 studies in Death, Sudden, Cardiac with a site in Germany are open now. Recruiting first, the newest first:
Charite University, Berlin, Germany · Sites in Germany, Austria, Belgium and 10 more countries
University of Luebeck · Sites in Germany
Western Sydney Local Health District · Sites in Germany, United States, Australia and 12 more countries
Klinik für Kardiologie, Pneumologie und Angiologie · Sites in Germany
Universitätsklinikum Köln · Sites in Germany
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 63 Death, Sudden, Cardiac studies recruiting now, 41 (65%) set no upper age limit and 11 (17%) stop at 75 or younger; 21 take children under 18; 7 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
43 studies; the count open now beside each. This study's row is marked.
First in 1993; this study’s year is marked. 1 started in 2025.
This study's planned enrollment of 20 is below the median of 126 across 135 interventional studies indexed under Death, Sudden, Cardiac.
Median enrollment 180 across the 18 interventional studies, 410 across the 24 observational. Of the 27 that completed or were terminated, 4 (15%) have results posted.
This tab as a report to print or save as PDF → With an account.
10 of 43 have an industry lead sponsor. The 10 most frequent:
Universitätsklinikum Köln is the lead sponsor of 33 studies on the registry; 5 are open to participants now.
Universitätsklinikum Köln has 2 studies filed under Death, Sudden, Cardiac — fewer than ten, so there is no comparison to draw.
1 of the studies in Death, Sudden, Cardiac with a site in Germany that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05665608Charite University, Berlin, GermanyPrevention Of Sudden Cardiac Death After Myocardial Infarction by Defibrillator Implantation | 2027-11-30 |
Among the 43 studies in Death, Sudden, Cardiac with a site in Germany, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
This trial investigates two key aspects of S-ICD implantation. 1) To achieve successful shock conversion of an arrhythmia with the S-ICD, the optimal position of the electrode and the device are paramount. A pre-operative x-ray-based assessment of the anatomy and location of the heart is required. Using a dummy electrode and device placed on the patient's chest, the desired position is determined through fluoroscopy, and it is marked on the patient's skin. In this trial US will be used to determine the ideal lead and device position. As the current standard, the X-ray method will then confirm ideal positioning before the device is implanted.
2) The PRAETORIAN score is an established tool to predict defibrillation test success in subcutaneous ICD implantation but can only be calculated post-procedure using chest X-ray. This pilot study aims to evaluate the feasibility of determining the PRAETORIAN score intra-operatively. This pilot study will assess whether lead-to-sternum distance and generator position can be accurately measured during the implantation procedure by manual measurements with non-fluoroscopic means. This would potentially allow risk stratification before intra-operative defibrillation testing. Ten 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. If successful, this approach could improve implantation safety by identifying high-risk patients before defibrillation testing.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Diagnostic Test: Intraoperative PRAETORIAN Score
The intraoperative PRAETORIAN Score is calculated based on the additional measurements.
PRAETORIAN
The intraoperative PRAETORIAN Score is correlated with the regular PRAETORIAN Score
Time frame: 1 day after the device implantation, when chest x-ray is available
Plan to share: No — This is a pilot study with potential proprietary data
No publications or documents are linked to this record.
Started Mar 2025 (actual). Primary completion is estimated for Oct 2025, 7 months after the start.
Of 47 non-industry interventional studies with no phase under Death, Sudden, Cardiac, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 86. This study's planned 7 months is below that.
Counting every sponsor, half of 56 studies reached it within 42 months; a quarter within 17 and three quarters within 83.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Universitätsklinikum Köln