Magnetic Resonance (MR) Conditional Tachyarrhythmia Therapy Products Post-approval Study

Study Overview
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Brief Summary
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Following product approval, further confirmation of the MR Conditional Tachyarrhythmia Therapy Systems sensing and detection performance post MRI exposure will be obtained by actively monitoring de-identified device data obtained through the Medtronic CareLink® Network.

Detailed Description
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Pre-clinical testing and clinical data has demonstrated the safety and effectiveness of magnetic resonance (MR) Conditional Tachyarrhythmia Therapy Systems in the MR environment when used according to labeling requirements. Following approval, further confirmation of the MR Conditional Tachyarrhythmia Therapy Systems sensing and detection performance post MRI exposure will be obtained by actively monitoring de-identified device data obtained through the Medtronic CareLink® Network. MR conditional tachyarrhythmia therapy system enrolled in the Medtronic CareLink® Network (CL) will be used to prospectively assess spontaneous Ventricular Fibrillation (VF) episode detection following MRI exposure.

Official Title
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Medtronic Magnetic Resonance (MR) Conditional Tachyarrhythmia Therapy Products Post-approval Study

Conditions
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Tachyarrhythmia

Intervention / Treatment
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* Device: Implant of an MR-conditional Tachy device system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: MR conditional tachyarrhythmia therapy system enrolled in the Medtronic CareLink® Network (CL) will be used to prospectively assess spontaneous Ventricular Fibrillation (VF) episode detection following MRI exposure.
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 |
| --- | --- |
| Patients implanted with an MR-conditional Tachy device system<br>Patients implanted with an MR-conditional Tachy device system in the routine care | Device: Implant of an MR-conditional Tachy device system<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of episodes with ≥ 5 seconds VF detection delay in the MR conditional tachyarrhythmia therapy system following MRI exposure. | The primary objective will be analyzed and reported when 50 patients with a true VF episode following MR exposure have been identified | up to 5 years post-approval. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients with 2 or more scans | The estimate of patients receiving multiple MRI scans will include all patients regardless if the patient has experienced a VF episode. | up to 5 years post-approval | 
| Pre-MRI and post-MRI LV lead PCT measurements obtained through CareLink | Pre-MRI and post-MRI LV lead PCT measurements obtained through CareLink will be summarized for MR CRT-D patients. Summary statistics will be presented separately for pre-MRI and post-MRI PCT measurements | up to 5 years post-approval |