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

Not Applicable

Completed

• Conditions: Congenital Heart Defect
• Interventions: Procedure: XFM guidance

• Registration Number: NCT02737579
• Lead Sponsor: Joshua Kanter

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.

Study Timeline

• Study Start: 2013-07-23
• Study First Submitted: 2016-02-17
• Study First Submitted QC: 2016-04-11
• Study First Posted: 2016-04-14
• Primary Completion: 2022-05-27
• Study Completion: 2022-05-27
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
XFM guidance	XFM guidance	X-ray fused cardiac MRI images used for guidance tool to perform cardiac catheterization procedure

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Children's National Health System; 🇺🇸 Washington, District of Columbia, United States