arrhythmia
Conditions
Interventions
Two out of three subjects will obtain a MRI scan 9-12 weeks after the
implantation.
Evera MRI
MRI scan
Sponsors
Medtronic Trading NL BV
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Patient is indicated for the first time for an ICD implantation Patient is willing and able to undergo elective MRI scanning
Exclusion criteria
Exclusion criteria: Patient has contraindication for an ICD. Patient has contraindication for an elective MRI scan.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objectives: Safety: To demonstrate an acceptable MRI-related event-free rate. Efficacy: To demonstrate that the proportion of patients whose ventricular pacing capture threshold increases significantly one month post-MRI/waiting period is similar between the MRI group and the control group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objectives: - To demonstrate an acceptable system-related complication rate. - To demonstrate the system integrity of the high-voltage ICD component after MRI exposure. - To demonstrate that the proportion of patients whose atrial pacing capture threshold increases significantly one month post-MRI/waiting period is similar between the MRI group and the control group. | — |
Countries
The Netherlands
Outcome results
None listed