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COMPLETED
NCT01117792
NA

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

Sponsor: Boston Scientific Corporation

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

55

Start Date

2008-12

Completion Date

2009-08

Last Updated

2026-09-30

Healthy Volunteers

No

Interventions

DEVICE

subcutaneous implantable defibrillator (S-ICD) system

implantable defibrillator system

Locations (8)

Policlinico San Donato

San Donato Milanese, Italy

Academisch Medisch Centrum

Amsterdam, Netherlands

Universitair Medisch Centrum

Groningen, Netherlands

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

Erasmus Medical Center

Rotterdam, Netherlands

Auckland City Hospital

Auckland, New Zealand

Christchurch Hospital

Christchurch, New Zealand

Russells Hall Hospital

Dudley, United Kingdom