Clinical trial NCT02737579: XFM: (X-ray Fused With MRI) Guided Cardiac Catheterization
Official title: XFM: (X-ray Fused With MRI) Guided Cardiac Catheterization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Defect
Keywords: cardiac catheterization
cardiac MRI
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
First posted: 2016-04-14
Enrollment: 27
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Radiation exposure measurement
timeFrame: At the end of each catheterization procedure through study completion,up to 8 years.
Secondary outcomes:
measure: Fluoroscopy time measurement
timeFrame: At the end of each catheterization procedure through study completion,up to 8 years.
measure: Contrast volume measurement
timeFrame: At the end of each catheterization procedure through study completion, up to 8 years.
measure: Procedure time measurement
timeFrame: At the end of each catheterization procedure through study completion,up to 8 years.
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Health System
state: District of Columbia
Study officials:
affiliation: Children's National Hospital System
name: Joshua Kanter, MD
role: PRINCIPAL_INVESTIGATOR
References:
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