S-ICD Implantation: US Based Pilot Study

NCT ID: NCT06771700

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2025-11-01

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.

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.

Conditions

Sudden Cardiac Death

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Intraoperative PRAETORIAN Score

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Intraoperative PRAETORIAN Score

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• patients unable to consent.
• pregnancy

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsklinikum Köln

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital Cologne

Cologne, North Rhine-Westphalia, Germany

Site Status: NOT_YET_RECRUITING

University Hospital Cologne

Cologne, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Jakob Luker, MD

Role: CONTACT

jakob.luker@uk-koeln.de

+4947832396

Jonas Worman, MD

Role: CONTACT

jonas.worman@uk-koeln.de

+4947832396

Facility Contacts

Jakob Luker, MD

Role: primary

jakob.lueker@uk-koeln.de

+4947832396

Jakob Luker, MD

Role: primary

jakob.luker@uk-koeln.de

+4947832396

Jonas Worman, MD

Role: backup

jones.worman@uk-koeln.de

Other Identifiers

UKK2025_SICDImplant

Identifier Type: -

Identifier Source: org_study_id