Patients With Implantable Cardiac Devices Requiring a Nuclear Magnetic Resonance

Study Overview
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Brief Summary
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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
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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

Official Title
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Spanish Registry of Patients With Implantable Cardiac Devices That Require a Diagnostic Imaging Test With Nuclear Magnetic Resonance

Conditions
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Implantable Cardiac Device. Patients With a NMR Indication

Intervention / Treatment
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* Device: Biotronik peacemakers, implantable cardioverter-defibrillators and cardiac resynchronizers


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Biotronik 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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with implantable cardiac devices that require a diagnostic test based on MRI | statistical analysis of the variable | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary indication for MRI | statistical analysis of the variable | 1 year | 
| Reasons for not used MRI | statistical analysis of the variable | 1 year | 
| 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 | statistical analysis of the variable | 1 year | 
| Cost effectiveness of the he MRI Autodetect function | statistical analysis of the variable | 1 year | 
| Analysis of the differences in the workflow | statistical analysis of the variable | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peacemaker, implantable cardioverter-defibrillator, Nuclear Magnetic Resonance