Patients With Implantable Cardiac Devices Requiring a Nuclear Magnetic Resonance (RESONANCE)

Trialance

Status: Unknown

Conditions: Implantable Cardiac Device. Patients With a NMR Indication

Treatments: Device: Biotronik peacemakers, implantable cardioverter-defibrillators and cardiac resynchronizers

Study type: Observational

Funder types: Industry

Identifiers

NCT04330898

RMN01

Details and patient eligibility

About

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.

Full 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

Enrollment: 1,248 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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