Abandoned Endocardial Leads, Broken Endocardial Leads, Permanent Epicardial Leads
Conditions
Keywords
Cardiac Magnetic Resonance Imaging
Brief summary
This is a prospective cohort study looking to systematically evaluate the safety of conducting cardiac Magnetic Resonance Imaging (MRI) in this high-risk patient group with abandoned, fractured endocardial leads or surgically implanted permanent epicardial leads, by monitoring clinical outcome and device functionality (if active device present).
Detailed description
This is a prospective cohort study involving patients with abandoned, fractured endocardial leads, or surgically placed permanent epicardial leads with or without concurrent active cardiac implantable electronic devices (CIEDs), who need cardiac MRI for clinical indications. Participants will undergo a thorough pre-scan evaluation, including chest x-ray (CXR), device interrogation, lead integrity check, and risk assessment. The MRI will be performed using a standardized protocol designed to minimize risks, with continuous patient monitoring during the procedure. Post-scan device interrogation and patient evaluation will assess any immediate and delayed adverse effects. This study is a descriptive case series, and no statistical comparisons with controls will be made. Descriptive statistics of continuous patient and CIED variables are expressed as the mean+/- SDs (standard deviations), or as medians with interquartile ranges (IOR). Categorical variables are expressed as numbers and percentages.
Interventions
DEVICECardiac MRI (CMR)
Conducting cardiac MRI in a high-risk patient group with abandoned, fractured endocardial leads or surgically implanted permanent epicardial leads, by monitoring clinical outcome and device functionality (if active device present) to determine the diagnostic value of Cardiac MRI in these patients.
Sponsors
Baylor Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Individuals 18 years and older * Individuals with abandoned, fractured endocardial * Individuals with permanent epicardial pacemaker or implantable cardioverter-defibrillator (ICD) leads
Exclusion criteria
Within 6 weeks post device implantation, unless more urgent clinical needs dictate an earlier scan; * Pregnant individuals * Individuals with severe claustrophobia * Individuals with other known contraindications for MRI, as determined by study doctor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluating the safety of CMR | 6 months | To systematically evaluate the safety of conducting cardiac Magnetic Resonance Imaging (MRI) in this high-risk patient group with abandoned, fractured endocardial leads or surgically implanted permanent epicardial leads, by monitoring clinical outcome and device functionality (if active device present). This is done by evaluating and reviewing the CMR images. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Value of CMR | 6 months | To determine the diagnostic value of cardiac MRI in these patients, including the quality of imaging and the ability to address clinical questions. This is done by evaluating and reviewing the CMR images. |
| Protocol Development. | 2 years. | To develop and refine cardiac MRI protocols that effectively minimize risks while maintaining diagnostic quality in this patient group. This is done by taking the results of the CMR imaging and data collected and implementing changes to future protocol to minimize risks. |
Countries
United States
Outcome results
None listed