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Completed

NCT Number: NCT02737579

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's National Health System

Washington D.C., District of Columbia, 20010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children and adults of any age
  • Undergoing clinically-indicated cardiovascular catheterization

Exclusion criteria

  • Cardiovascular instability precluding baseline medially-necesary MRI
  • Women who are pregnant
  • Women who are nursing and who do not plan to discard breast milk for 24 hours
  • All patients who are medically judged to have contraindication(s) to MRI scanning. Contraindications include implanted metal devices which are contraindicated for MRI scanning

Treatment and study plan

XFM guidance

Procedure

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Joshua Kanter

Other

Registry information

Important dates

Study start
2013
Primary completion
2022
Study completion
2022
First posted
Apr 14, 2016
Registry last updated
Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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