Tachy Prediction Download Study

Study Overview
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Brief Summary
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The purpose of the Medtronic Tachy Prediction Download (TPD) study is to collect data from an implantable cardiac defibrillator (ICD) device that will be used to identify markers for imminent onset of ventricular arrhythmias.

Detailed Description
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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.

Official Title
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Tachy Prediction Download Study

Conditions
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Ventricular Tachycardia

Intervention / Treatment
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* Other: TPD RAMWare


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TPD RAMWare Download<br>Subjects who qualify and consent to participate in the TPD study will have TPD RAMWare injected into their device to collect data. | Other: TPD RAMWare<br>* TPD RAMWare injected into enrolled subject's Implantable cardioverter-defibrillator (ICD) device for use<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Device Detected Ventricular Tachycardia/Ventricular Fibrillation Episodes | This was a data collection study collecting data when implanted device detected Ventricular Tachycardia/Ventricular Fibrillation. | 1 year |