XFM: (X-ray Fused With MRI) Guided Cardiac Catheterization

Study Overview
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Brief Summary
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This study will evaluate the use of x-ray fused with MR images as an imaging tool to help guide catheter tools during diagnostic and therapeutic cardiac catheterization procedures.

Detailed Description
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Cardiovascular interventional procedures are currently conducted under the guidance of X-ray fluoroscopy. Magnetic resonance imaging (MRI) can provide increased soft tissue information about the cardiovascular system. By combining the familiar X-ray environment with superior magnetic resonance imaging, the investigator hopes to enhance and expand the capabilities of cardiac catheterization techniques. The investigator will conduct cardiac catheterization procedures using XFM guidance in pediatric research patients who are undergoing medically necessary procedures. The investigator aims to decrease the exposure of these patients to the routine hazards of ionizing radiation and contrast exposure compared to the standard of care approach.

Official Title
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XFM: (X-ray Fused With MRI) Guided Cardiac Catheterization

Conditions
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Congenital Heart Defect

Intervention / Treatment
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* Procedure: XFM guidance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children and adults of any age Undergoing clinically-indicated cardiovascular catheterization Exclusion Criteria: Cardiovascular instability precluding baseline medially-necesary MRI Women who are pregnant Women who are nursing and who do not plan to discard breast milk for 24 hours All patients who are medically judged to have contraindication(s) to MRI scanning. Contraindications include implanted metal devices which are contraindicated for MRI scanning
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: XFM guidance<br>X-ray fused cardiac MRI images used for guidance tool to perform cardiac catheterization procedure | Procedure: XFM guidance<br>* X-ray images and MRI roadmaps are aligned, during the medically indicated catheterization procedure, both conventional X-ray and investigational XFM images are displayed side-by-side. The operator may choose to be guided by either.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation exposure measurement | Comparisons with data from historical controls undergoing matched invasive cardiology procedures at Children's National Medical Center | At the end of each catheterization procedure through study completion,up to 8 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluoroscopy time measurement | Comparisons with data from historical controls undergoing matched procedures at Children's National Medical Center | At the end of each catheterization procedure through study completion,up to 8 years. | 
| Contrast volume measurement | Comparisons with data from historical controls undergoing matched invasive cardiology procedures at Children's National Medical Center will be examined. | At the end of each catheterization procedure through study completion, up to 8 years. | 
| Procedure time measurement | Comparisons with data from historical controls undergoing matched procedures at Children's National Medical Center | At the end of each catheterization procedure through study completion,up to 8 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac catheterization, cardiac MRI