Bradycardia
Conditions
Keywords
Pacemaker, leads and MRI exam
Brief summary
The purpose of this study is to report the stability of atrial and ventricular leads by absence of effect of the MRI exam on the pacing and sensing threshold and to report the safety based on the serious adverse events.
Interventions
DEVICEMRI
at least 6 weeks after the implantation of the pacemaker a MRI exam is performed
Sponsors
MicroPort CRM
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient who is already implanted with following system KORA 100 (SR or DR) pacemaker and Beflex RF45D and/or RF46D pacing leads in the left or right pectoral region * Patient who is able and willing out-of-chest non medical indicated MRI scanning OR patients with planned medical indicated out of chest MRI scanning * Patient who fulfils MRI solutions conditions * Patient who provides signed and dated informed consent
Exclusion criteria
* Implanted or planned to be implanted non MR-compatible device or material * Permanent Atrial Fibrillation (for DR devices) * Diaphragmatic/phrenic stimulation * Claustrophobia * Incessant ventricular tachyarrhythmia * Inability to understand the purpose of the study or refusal to co-operate * Unavailability for scheduled follow-ups at the implanting centre * Already included in another clinical trial that could affect the results of this study * Patient is minor (less than 18-years old) * Patient is pregnant - Patient is forfeiture of freedom or under guardianship
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measure the atrial and ventricular pacing thresholds in Volts before and after the MRI exam, using the programmer. | 1 month |
Countries
France
Outcome results
None listed