Tachyarrhythmia
Conditions
Brief 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.
Interventions
DEVICEImplant of an MR-conditional Tachy device system
Sponsors
Medtronic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of episodes with ≥ 5 seconds VF detection delay in the MR conditional tachyarrhythmia therapy system following MRI exposure. | up to 5 years post-approval. | The primary objective will be analyzed and reported when 50 patients with a true VF episode following MR exposure have been identified |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of patients with 2 or more scans | up to 5 years post-approval | The estimate of patients receiving multiple MRI scans will include all patients regardless if the patient has experienced a VF episode. |
| Pre-MRI and post-MRI LV lead PCT measurements obtained through CareLink | up to 5 years post-approval | 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 |
Outcome results
None listed