Tachy Prediction Download Study

The TPD Study is a prospective, non-randomized, non-interventional, multi-site data
collection clinical study to collect ICD longitudinal data that may be used to develop a
VT/VF prediction algorithm. The study subjects will include patients currently implanted, or
who will be implanted with a market-approved Medtronic Evera MRI® ICD.

Inclusion Criteria:

- Subject is implanted or will be implanted, with an Evera MRI device with properly
functioning Medtronic tachycardia lead placed in the right ventricle (with or without
atrial lead) with remaining device longevity of 4 years or more for:

- Secondary Prevention or,

- Primary Prevention and has had a device treated VT/VF or a device recorded
episode of sustained VT/VF

- Subject is ≥ 18 years old

- Subject has previously documented history of VT/VF

- Subject must be willing and able to use Medtronic CareLink network monitoring system

- Subject provides signed and dated authorization and/or consent per institution and
local requirements

- Subject is willing and able to comply with the protocol

Exclusion Criteria:

- Subject who received device for Primary Prevention indication and who has not had
either a device treated VT/VF episode or a device recorded episode of sustained VT/VF

- Subject is enrolled in a concurrent study that may confound the results of this study,
without documented pre-approval from a Medtronic study manager

- Subject has chronic AF

- Subject has inherited disorders of ion transport mechanisms that predispose the
subject to sudden death ("Channelopathies"): Long QT and Brugada Syndromes

- Subject with multiple implanted active devices that may cause an interruption of a
transmission of device data to CareLink

- Subject has active electronic medical device other than an ICD

- Subject requires more than 25% atrial or ventricular pacing

- Subject has medical conditions that would limit study participation (per investigator
judgment)

- Subject has projected life expectancy of less than 1 year

- Subject is pregnant or plans to be pregnant over the next year (females of
child-bearing potential must have a negative pregnancy test within one week of
enrollment and must practice a reliable form of birth control while enrolled in the
study)

- Subject meets exclusion criteria required by local law (e.g. age, breastfeeding, etc.)