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

Joshua Kanter

Status: Completed

Conditions: Congenital Heart Defect

Treatments: Procedure: XFM guidance

Study type: Interventional

Funder types: Other

Identifiers

NCT02737579

Internal Bridge Funding (Other Grant/Funding Number)

3879

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

XFM guidance

Other group

Description:

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

Treatment:

Procedure: XFM guidance