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

Joshua Kanter27 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Congenital Heart Defect

Interventions

XFM guidancePROCEDURE

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Children's National Health System

Washington D.C., District of Columbia, United States

Outcomes

Primary Outcomes

Radiation exposure measurement

Comparisons with data from historical controls undergoing matched invasive cardiology procedures at Children's National Medical Center

Time frame: At the end of each catheterization procedure through study completion,up to 8 years.

Secondary Outcomes

Fluoroscopy time measurement

Comparisons with data from historical controls undergoing matched procedures at Children's National Medical Center

Time frame: 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.

Time frame: 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

Time frame: At the end of each catheterization procedure through study completion,up to 8 years.

Data from ClinicalTrials.gov

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