Pacemakers, Magnetic Resonance Imaging, hartritmestoornis,bradyaritmie
Conditions
Interventions
Subjects are enrolled when already implanted according to standard medical guidelines for pacemaker implantation and will undergo a Magnetic Resonance Imaging (MRI) scan under the labeled Conditions o
Sponsors
study sponsored by:
Guidant Europe SA / NV,
a Boston Scientific Company
Clinical CRM Department
Green Square
Lambroekstraat 5D
1831 Diegem,
Belgium
Eligibility
Inclusion criteria
Inclusion criteria: • Age 18 or above, or above legal age and willing and capable of giving informed consent specific to national law • Patients already implanted with ImageReady™ MR Conditional Pacing System, according to standard medical guidelines for pacemaker implantation. • Willing and capable of participation to the procedures indicated in the protocol.
Exclusion criteria
Exclusion criteria: • Patients implanted with other cardiac-related implanted devices or accessories other than the ImageReadyTM MR Conditional Pacing System • Low life expectancy (< 1 year) • Severe comorbidities that, according to clinical judgment, pose patient at risk to undergo MRI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study is aimed at providing confirmatory data of no impact of MRI on device function, lead parameters and patient conditions for the CE-marked ImageReady™ MR Conditional Pacing System when used under the labeled Conditions of Use. | — |
Contacts
Public ContactPhone: +39 348 2502687 Giovanni Raciti
E-mail: Giovanni.Raciti@bsci.com
Outcome results
None listed