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Subcutaneous Implantable Defibrillator (S-ICD) System - CE Clinical Investigation
Sponsor: Boston Scientific Corporation
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
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