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Clinical Trial 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.


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms

  • Implantable Cardiac Device. Patients With a NMR Indication

NCT number NCT04330898
Study type Observational [Patient Registry]
Source Trialance SCCL
Contact Xavier Molina Figueras, PharmD, PhD
Phone + 34 689900009
Email xmolina@trialance.com
Status Recruiting
Phase
Start date May 2, 2017
Completion date July 30, 2020