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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02737579
Recruitment Status : Active, not recruiting
First Posted : April 14, 2016
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Joshua Kanter, Children's Research Institute

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.

Condition or disease Intervention/treatment Phase
Congenital Heart Defect Procedure: XFM guidance Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: XFM: (X-ray Fused With MRI) Guided Cardiac Catheterization
Study Start Date : November 2013
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: X-Rays
Drug Information available for: X-Rays

Arm Intervention/treatment
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737579


Locations
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United States, District of Columbia
Children's National Health System
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Joshua Kanter
Investigators
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Principal Investigator: Joshua Kanter, MD Children's National Hospital System

Publications:

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Responsible Party: Joshua Kanter, Joshua Kanter, MD, Children's Research Institute
ClinicalTrials.gov Identifier: NCT02737579    
Other Study ID Numbers: 3879
Internal Bridge Funding ( Other Grant/Funding Number: Children's Research Institute, Children's National )
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Joshua Kanter, Children's Research Institute:
cardiac catheterization
cardiac MRI
Additional relevant MeSH terms:
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Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities