S-ICD Implantation: US Based Pilot Study

NCT06771700 | Recruiting

• 1 other identifier: UKK2025_SICDImplant
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Sudden Cardiac Death

Keywords

S-ICD; Defibrillator

Outcome Measures

Primary Outcomes (1)

• PRAETORIAN

  The intraoperative PRAETORIAN Score is correlated with the regular PRAETORIAN Score

  1 day after the device implantation, when chest x-ray is available

Study Arms (1)

S-ICD Implantation

EXPERIMENTAL

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

Interventions

Intraoperative PRAETORIAN Score DIAGNOSTIC_TEST

The intraoperative PRAETORIAN Score is calculated based on the additional measurements.

S-ICD Implantation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• patients unable to consent.
• pregnancy

Sponsors & Collaborators

• Universitätsklinikum Köln: lead

Study Sites (2)

University Hospital Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

NOT YET RECRUITING

University Hospital Cologne

Cologne, 50823, Germany

RECRUITING

MeSH Terms

Conditions

Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jakob Luker, MD

CONTACT

+4947832396; jakob.luker@uk-koeln.de

Jonas Worman, MD

CONTACT

+4947832396; jonas.worman@uk-koeln.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a pilot study. Patients are treated according to clinical standard. There are additional measurements made in the process but the study protocol does NOT include any deviation from the clinical standard practice.

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 13, 2025
• Study Start: March 1, 2025
• Primary Completion: October 30, 2025
• Study Completion: November 1, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)