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

Tachyarrhythmia Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02849769
Study type Observational
Source Medtronic
Contact
Status Completed
Phase
Start date September 2015
Completion date May 2019
View Details
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