NCT02849769

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10,979 (actual)
• Sponsor: Medtronic · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Tachyarrhythmia

Interventions

Type	Name	Description
DEVICE	Implant of an MR-conditional Tachy device system

Timeline

• Start date: 2015-09-01
• Primary completion: 2018-12-01
• Completion: 2019-05-01
• First posted: 2016-07-29
• Last updated: 2019-06-05