This is an acute, prospective, multi-center, non-randomized, investigational device exemption (IDE) clinical study.
The purpose of this study is to confirm the performance of new sensing circuitry, and to confirm the performance of a Ventricular Capture Management feature in subjects with implantable cardioverter defibrillator (ICD) leads connected to an external pacemaker/defibrillator.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
65
Unnamed facility
Tampa, Florida, United States
Unnamed facility
Coon Rapids, Minnesota, United States
Unnamed facility
Rochester, Minnesota, United States
Unnamed facility
Saint Paul, Minnesota, United States
Unnamed facility
Ventricular fibrillation (VF) detection time
Ventricular Capture Management accuracy
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Charlotte, North Carolina, United States