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

Primary Purpose

Congenital Heart Defect

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
XFM guidance
Sponsored by
Joshua Kanter
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Congenital Heart Defect focused on measuring cardiac catheterization, cardiac MRI

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's National Health System

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

XFM guidance

Arm Description

X-ray fused cardiac MRI images used for guidance tool to perform cardiac catheterization procedure

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Fluoroscopy time measurement
Comparisons with data from historical controls undergoing matched procedures at Children's National Medical Center
Contrast volume measurement
Comparisons with data from historical controls undergoing matched invasive cardiology procedures at Children's National Medical Center will be examined.
Procedure time measurement
Comparisons with data from historical controls undergoing matched procedures at Children's National Medical Center

Full Information

First Posted
February 17, 2016
Last Updated
March 28, 2022
Sponsor
Joshua Kanter
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1. Study Identification

Unique Protocol Identification Number
NCT02737579
Brief Title
XFM: (X-ray Fused With MRI) Guided Cardiac Catheterization
Official Title
XFM: (X-ray Fused With MRI) Guided Cardiac Catheterization
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 23, 2013 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Joshua Kanter

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Defect
Keywords
cardiac catheterization, cardiac MRI

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
XFM guidance
Arm Type
Other
Arm Description
X-ray fused cardiac MRI images used for guidance tool to perform cardiac catheterization procedure
Intervention Type
Procedure
Intervention Name(s)
XFM guidance
Intervention Description
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 Measure Information:
Title
Radiation exposure measurement
Description
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 Outcome Measure Information:
Title
Fluoroscopy time measurement
Description
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.
Title
Contrast volume measurement
Description
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.
Title
Procedure time measurement
Description
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.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua Kanter, MD
Organizational Affiliation
Children's National Hospital System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's National Health System
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17101858
Citation
de Silva R, Gutierrez LF, Raval AN, McVeigh ER, Ozturk C, Lederman RJ. X-ray fused with magnetic resonance imaging (XFM) to target endomyocardial injections: validation in a swine model of myocardial infarction. Circulation. 2006 Nov 28;114(22):2342-50. doi: 10.1161/CIRCULATIONAHA.105.598524. Epub 2006 Nov 13.
Results Reference
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PubMed Identifier
18022851
Citation
Gutierrez LF, Silva Rd, Ozturk C, Sonmez M, Stine AM, Raval AN, Raman VK, Sachdev V, Aviles RJ, Waclawiw MA, McVeigh ER, Lederman RJ. Technology preview: X-ray fused with magnetic resonance during invasive cardiovascular procedures. Catheter Cardiovasc Interv. 2007 Nov 15;70(6):773-82. doi: 10.1002/ccd.21352.
Results Reference
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PubMed Identifier
23464334
Citation
Faranesh AZ, Kellman P, Ratnayaka K, Lederman RJ. Integration of cardiac and respiratory motion into MRI roadmaps fused with x-ray. Med Phys. 2013 Mar;40(3):032302. doi: 10.1118/1.4789919.
Results Reference
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PubMed Identifier
21361182
Citation
George AK, Sonmez M, Lederman RJ, Faranesh AZ. Robust automatic rigid registration of MRI and X-ray using external fiducial markers for XFM-guided interventional procedures. Med Phys. 2011 Jan;38(1):125-41. doi: 10.1118/1.3523621.
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PubMed Identifier
18404935
Citation
Gutierrez LF, Ozturk C, McVeigh ER, Lederman RJ. A practical global distortion correction method for an image intensifier based x-ray fluoroscopy system. Med Phys. 2008 Mar;35(3):997-1007. doi: 10.1118/1.2839099.
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XFM: (X-ray Fused With MRI) Guided Cardiac Catheterization

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