This study is designed to provide continued access to the Extravascular Implantable Cardioverter Defibrillator (EV ICD) System.
The study will enroll subjects who are indicated to receive an implantable defibrillator who meet all of the inclusion criteria and none of the exclusion criteria. Subjects will receive an investigational Extravascular Implantable Cardioverter Defibrillator (EV ICD) system, in which a lead is placed outside of the heart and veins to deliver defibrillation therapy. Subjects will be followed every 6 months following system implantation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
VT/VF induction attempted for defibrillation testing, as well as requisite electrical testing.
Complications
EV ICD system and/or procedure related adverse events
Time frame: Through study completion, an average of 18 months
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