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

Medtronic

Status: Completed

Conditions: Tachyarrhythmia

Treatments: Device: Implant of an MR-conditional Tachy device system

Study type: Observational

Funder types: Industry

Identifiers

NCT02849769

MR Tachy PAS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10,979 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

10,979 participants in 1 patient group

Patients implanted with an MR-conditional Tachy device system

Description:

Patients implanted with an MR-conditional Tachy device system in the routine care

Treatment:

Device: Implant of an MR-conditional Tachy device system