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

February 5, 2024 updated by: Joshua Kanter
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Children's National Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: XFM guidance
X-ray fused cardiac MRI images used for guidance tool to perform cardiac catheterization procedure
Procedure: XFM 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiation exposure measurement
Time Frame: 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
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
Time Frame: 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
At the end of each catheterization procedure through study completion,up to 8 years.
Contrast volume measurement
Time Frame: 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.
At the end of each catheterization procedure through study completion, up to 8 years.
Procedure time measurement
Time Frame: 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
At the end of each catheterization procedure through study completion,up to 8 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joshua Kanter

Investigators

  • Principal Investigator: Joshua Kanter, MD, Children's National Hospital System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 23, 2013

Primary Completion (Actual)

May 27, 2022

Study Completion (Actual)

May 27, 2022

Study Registration Dates

First Submitted

February 17, 2016

First Submitted That Met QC Criteria

April 11, 2016

First Posted (Estimated)

April 14, 2016

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3879
  • Internal Bridge funding (Other Identifier: Children's Research Institute, Children's National)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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