Subcutaneous Implantable Defibrillator (S-ICD) System - CE Clinical Investigation

Not Applicable

Completed

• Conditions: ACC/AHA/NASPE Class 1, IIa or IIb Indications
• Interventions: Device: subcutaneous implantable defibrillator (S-ICD) system

• Registration Number: NCT01117792
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

The primary objective is to evaluate the S-ICD system's ability to identify and terminate induced ventricular fibrillation in patients during the implant procedure. The safety and performance of the S-ICD system will also be assessed throughout the patient follow-up period.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Primary Completion: 2009-03
• Study Completion: 2009-08
• Study First Submitted: 2010-04-28
• Study First Submitted QC: 2010-05-04
• Study First Posted: 2010-05-05
• Results First Submitted: 2021-06-11
• Status Verified: 2021-07
• Results First Submitted QC: 2021-07-01
• Last Update Submitted: 2021-07-01
• Results First Posted: 2021-07-02
• Last Update Posted: 2021-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• Replacement of an existing implanted transvenous ICD system
• Class I, Class IIa, or Class IIb ACC/AHA/HRS indications for patients without an existing transvenous ICD system
• Age is >= 18 years
• Appropriate pre-operative ECG as measured with a specially developed template

Exclusion Criteria

• Subjects unable or unwilling to provide informed consent
• Any condition which precludes the subject's ability to comply with the study requirements
• Females who are pregnant or lactating and pre-menopausal women who are unwilling to use adequate birth control for the duration of the study
• Participation in another investigational device trial at any time during the conduct of the S-ICD system trial without written consent from the sponsor.
• Patients with a serious medical condition and life expectancy of less than one year.
• Patients with documented spontaneous and frequently recurring VT that is reliably terminated with anti-tachycardia pacing
• Patients with existing epicardial patches or subcutaneous electrodes in the left thoracic quadrant
• Patients with impaired kidney function as measured by a Cockcroft-Gault Glomerular Filtration Rate (GFR) with a GFR <= 29.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
S-ICD System	subcutaneous implantable defibrillator (S-ICD) system	-

Primary Outcome Measures

Name	Time	Method
Conversion of Induced Ventricular Fibrillation	Testing done during the implant procedure	The total number of subjects the S-ICD System was successful at converting induced sustained ventricular fibrillation.

Trial Locations

Locations (8)

Academisch Medisch Centrum; 🇳🇱 Amsterdam, Netherlands

Universitair Medisch Centrum; 🇳🇱 Groningen, Netherlands

Policlinico San Donato; 🇮🇹 San Donato Milanese, Italy

St. Antonius Ziekenhuis; 🇳🇱 Nieuwegein, Netherlands

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands

Russells Hall Hospital; 🇬🇧 Dudley, United Kingdom

Christchurch Hospital; 🇳🇿 Christchurch, New Zealand

Auckland City Hospital; 🇳🇿 Auckland, New Zealand