S-ICD Implantation: US Based Pilot Study

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест Intraoperative PRAETORIAN Score
  The intraoperative PRAETORIAN Score is calculated based on the additional measurements.

Первичные конечные точки

• PRAETORIAN [Срок оценки: 1 day after the device implantation, when chest x-ray is available]

Критерии участия

Критерии включения

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

Критерии исключения

• patients unable to consent.
• pregnancy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Германия · 2 центра

• University Hospital Cologne — Cologne
• University Hospital Cologne — Cologne

Идентификаторы

NCT: NCT06771700 · UKK2025_SICDImplant

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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