No chance to meet the foreseen target of patients with study endpoint

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Patients with an Implantable Cardioverter Defibrillator (ICD) or a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device followed-up at community hospitals

No adverse event collected in this study

All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed

41 out of the 46 enrolled subjects completed a Holter recording with at least 12 hours of telemetry, but none of them reached any study endpoint.

Therefore enrollment and study were closed and foreseen analyses could have not been performed