Magnetic Resonance (MR) Conditional Tachyarrhythmia Therapy Products Post-approval Study
This trial is active, not recruiting.
|Start date||September 2015|
|End date||December 2020|
|Trial size||10979 participants|
|Trial identifier||NCT02849769, MR Tachy PAS|
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.
To characterize the proportion of episodes with ≥ 5 seconds VF detection delay in the MR conditional tachyarrhythmia therapy system following MRI exposure.
time frame: up to 5 years post-approval.
Male or female participants of any age.
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. Exclusion Criteria:
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