Completed

NCT Number: NCT07155135

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

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

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Key information

Conditions

Safety of MRI

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Southern California Heart Specialists

Pasadena, California, 91105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

have a mixed-lead CIED
clinical relevant MRI

Exclusion criteria

same manufactured CIED

Treatment and study plan

MRI

Diagnostic Test

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.

Primary outcomes

Evaluation of Changes in Device Battery Voltage (Volts)

Time frame: 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)

Time frame: 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

Time frame: 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 outcomes

Evaluation of Changes in Patient Clinical Outcomes (Rhythm, Symptoms, Cardiac Arrest, or Death) Before and After MRI

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Socal Heart

Industry

Registry information

Official study title

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

Acronym: MRIMLD

Important dates

Study start: 2021
Primary completion: 2025
Study completion: 2025
First posted: Sep 4, 2025
Registry last updated: Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.