Magnetic Resonance Imaging Safety in Patients With Non-Conditional, Mixed-Manufacturer Cardiac Implantable Electronic Devices
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Evaluation of Changes in Device Battery Voltage (Volts)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •have a mixed-lead CIED
- •clinical relevant MRI
Exclusion Criteria
- •same manufactured CIED
Outcomes
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(Immediately Prior to MRI and Immediately after MRI)
Investigators
Ryka Tashakkor
First Author
Socal Heart