Implantable Cardiac Device. Patients With a NMR Indication
Conditions
Keywords
Peacemaker, implantable cardioverter-defibrillator, Nuclear Magnetic Resonance
Brief summary
The general objective of this registry is to study the number of patients carrying an implantable cardiac device that have an indication for an imaging diagnosis based on nuclear magnetic resonance. Is wanted to know the cause of the indication of the diagnostic test based on MRI.
Detailed description
MRI is currently infra indicated in patients with cardiac stimulation devices and for this reason, the request for this imaging technique in these patients is complicated and, often, the MRI-based test is replaced by a CT scan that may not be so beneficial for the diagnosis. Current data indicate that, with cardiological control and maintaining basic safety precautions, MRI could be performed in patients with peacemakers and Implantable Cardioverter Defibrillators (ICD) that require it for clinical reasons, although it should be noted that currently, due to lack of data published, the absolute safety of an MRI in these patients and the protocol used in each case cannot be guaranteed. This registry proposal is to have data of all patients implanted with Biotronik cardiac stimulation devices and evaluate how many of them have an indication for an MRI-based diagnostic test, how many of them are already undergoing this diagnostic test, how many are given an tomography as an alternative to avoid subjecting patients to an MRI
Interventions
DEVICEBiotronik peacemakers, implantable cardioverter-defibrillators and cardiac resynchronizers
Any of these Biotronik cardiac stimulation devices with the Home Monitoring function activated for the remote control of patients
Sponsors
Trialance SCCL
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients carrying a cardiac stimulation device * Patients able to understand the nature of the procedure * Patients who give informed consent
Exclusion criteria
* Epicardial cables * Abandoned cables * Non-BIOTRONIK cables * Age \<18 years * Pregnant and breastfeeding * Subjects with irreversible brain damage caused by a pre-existing brain disease * Heart transplant 6 months prior to recruitment or expected within the next 3 months * Cardiac surgery 3 months prior to recruitment or planned for the next 3 months * Life expectancy less than 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with implantable cardiac devices that require a diagnostic test based on MRI | 1 year | statistical analysis of the variable |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Primary indication for MRI | 1 year | statistical analysis of the variable |
| Reasons for not used MRI | 1 year | statistical analysis of the variable |
| Percentage of patients with a non-MRI-based test diagnosis, although they had an indication for an MRI-based diagnostic test because of their disease | 1 year | statistical analysis of the variable |
| Cost effectiveness of the he MRI Autodetect function | 1 year | statistical analysis of the variable |
| Analysis of the differences in the workflow | 1 year | statistical analysis of the variable |
Countries
Spain
Contacts
Primary ContactXavier Molina Figueras, PharmD, PhD
Backup ContactMarta Barbacid Hernández, PharmD, MSc
Outcome results
None listed