S-ICD Implantation: US Based Pilot Study (SUSTAIN S-ICD)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sudden Cardiac Death
• Intervention / Treatment: Diagnostic test: Intraoperative PRAETORIAN Score

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jakob Luker, MD; Phone Number: +4947832396; Email: jakob.luker@uk-koeln.de
• Study Contact Backup: Name: Jonas Worman, MD; Phone Number: +4947832396; Email: jonas.worman@uk-koeln.de

Study Locations

• Germany
  • Cologne, Germany, 50823
    • Recruiting
    • University Hospital Cologne
    • Principal Investigator: Jakob Luker, MD
    • Contact: Jakob Luker, MD; Phone Number: +4947832396; Email: jakob.luker@uk-koeln.de
    • Contact: Jonas Worman, MD; Email: jones.worman@uk-koeln.de
  • NRW
    • Cologne, NRW, Germany, 50937
      • Not yet recruiting
      • University Hospital Cologne
      • Contact: Jakob Luker, MD; Phone Number: +4947832396; Email: jakob.lueker@uk-koeln.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• patients unable to consent.
• pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Diagnostic test: Intraoperative PRAETORIAN Score; The intraoperative PRAETORIAN Score is calculated based on the additional measurements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PRAETORIAN	The intraoperative PRAETORIAN Score is correlated with the regular PRAETORIAN Score	1 day after the device implantation, when chest x-ray is available

Collaborators and Investigators

• Sponsor: Universitätsklinikum Köln

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): October 30, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: January 7, 2025
• First Submitted That Met QC Criteria: January 7, 2025
• First Posted (Actual): January 13, 2025

Study Record Updates

• Last Update Posted (Actual): July 9, 2025
• Last Update Submitted That Met QC Criteria: July 3, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Defibrillator; S-ICD
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Heart Arrest; Death, Sudden; Death, Sudden, Cardiac; Death
• Other Study ID Numbers: UKK2025_SICDImplant

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a pilot study with potential proprietary data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No