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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
implantable defibrillator system
Policlinico San Donato
San Donato Milanese, Italy
Academisch Medisch Centrum
Amsterdam, Netherlands
Universitair Medisch Centrum
Groningen, Netherlands
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
Conversion of Induced Ventricular Fibrillation
The total number of subjects the S-ICD System was successful at converting induced sustained ventricular fibrillation.
Time frame: Testing done during the implant procedure
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