Assessment of the MRI Solution: KORA 100 and Beflex Pacing Leads System (IKONE)

MicroPort

Status

Completed

Conditions

Bradycardia

Treatments

Device: MRI

Study type

Interventional

Funder types

Industry

Identifiers

NCT02175797

IBMR02 - IKONE

Details and patient eligibility

About

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.

Enrollment

33 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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