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This is a prospective, non-randomized, multicenter, post market release study which will collect electrograms (EGMs) from patients at risk of a suspected insulation failure to the high voltage portion of the defibrillator lead and will evaluate the electrogram signals.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with an Implantable Cardioverter Defibrillator (ICD) or a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device followed-up at community hospitals
Subject is willing to sign and date the study Informed Consent form
Subject is at least 18 years of age (or older, if required by local law)
Subject is willing and able to wear a Holter monitor for up to 24 hours
Subject has been implanted with a Medtronic ICD or CRT-D device
Subject has an increased risk of lead insulation breach
Subject has medical conditions that would limit study participation
Subject is enrolled in one or more concurrent studies that would confound the results of this study