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.
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.
Study Type
OBSERVATIONAL
Enrollment
10,979
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
Time frame: up to 5 years post-approval.
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.
Time frame: 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
Time frame: up to 5 years post-approval
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