Safety of Magnetic Resonance Imaging With Patients Who Have Mixed Lead Cardiac Implantable Electronic Devices

Magnetic Resonance Imaging Safety in Patients With Non-Conditional, Mixed-Manufacturer Cardiac Implantable Electronic Devices

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07155135

Acronym

MRIMLD

Enrollment

Registered

2025-09-04

Start date

2021-07-01

Completion date

2025-08-18

Last updated

2025-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Safety of MRI

Keywords

cardiac implantable electronic devices, CIED, MRI, Magnetic Resonance Imaging, safety

Brief summary

This study is looking at the safety and efficacy of using MRIs with patients who have cardiac implantable electronic devices.

Detailed description

Magnetic resonance imaging (MRI) is a critical diagnostic tool known for its non-invasive nature and high-resolution imaging capabilities. However, its safety in patients with cardiac implantable electronic devices (CIEDs), particularly those with mixed-lead systems, remains a significant clinical concern. This report investigates the safety and efficacy of MRI in such patients, where generators and leads originate from different manufacturers and are not officially deemed MRI-conditional.

Interventions

DIAGNOSTIC_TESTMRI

Magnetic resonance imaging (MRI) is a vital diagnostic tool in modern medicine due to its ability to produce detailed images of the body's internal structures without using ionizing radiation.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* have a mixed-lead CIED * clinical relevant MRI

Exclusion criteria

* same manufactured CIED

Design outcomes

Primary

Measure	Time frame	Description
Evaluation of Changes in Device Battery Voltage (Volts)	Immediately Prior to MRI and Immediately after MRI	report Device Battery Voltage (in Volts) prior to the MRI and after the MRI and determine if there was a change in voltage greater than 10% from the initial measurement to the final measurement.
Evaluation of Changes in Lead Impedance (Ohms)	Immediately Prior to MRI and Immediately after MRI	report lead impedance (in Ohms) prior to the MRI and after the MRI and determine if there is a change in impedence greater than 20% from the initial measurement to the final measurement.
Evaluation of Changes in Lead Threshold (Voltage) Before and After MRI	Immediately Prior to MRI and Immediately after MRI	report lead threshold in (voltage) prior to MRI and after the MRI and determine if there is a change greater than10% from the initial measurement to the final measurement.

Secondary

Measure	Time frame	Description
Evaluation of Changes in Patient Clinical Outcomes (Rhythm, Symptoms, Cardiac Arrest, or Death) Before and After MRI	Immediately Prior to MRI and Immediately after MRI	We will review medical records and determine if there were any observed change in patient rhythm, symptoms (such as chest pain, syncope), cardiac arrest or death after the MRI was completed.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026