Congenital Heart Defect
Conditions
Keywords
cardiac catheterization, cardiac MRI
Brief summary
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
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.
Interventions
PROCEDUREXFM guidance
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.
Sponsors
Joshua Kanter
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Children and adults of any age 2. Undergoing clinically-indicated cardiovascular catheterization
Exclusion criteria
1. Cardiovascular instability precluding baseline medially-necesary MRI 2. Women who are pregnant 3. Women who are nursing and who do not plan to discard breast milk for 24 hours 4. All patients who are medically judged to have contraindication(s) to MRI scanning. Contraindications include implanted metal devices which are contraindicated for MRI scanning
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiation exposure measurement | At the end of each catheterization procedure through study completion,up to 8 years. | Comparisons with data from historical controls undergoing matched invasive cardiology procedures at Children's National Medical Center |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fluoroscopy time measurement | At the end of each catheterization procedure through study completion,up to 8 years. | Comparisons with data from historical controls undergoing matched procedures at Children's National Medical Center |
| Contrast volume measurement | At the end of each catheterization procedure through study completion, up to 8 years. | Comparisons with data from historical controls undergoing matched invasive cardiology procedures at Children's National Medical Center will be examined. |
| Procedure time measurement | At the end of each catheterization procedure through study completion,up to 8 years. | Comparisons with data from historical controls undergoing matched procedures at Children's National Medical Center |
Countries
United States
Outcome results
None listed