Purpose

Currently catheters used in heart catheterization procedures are guided throughout the heart chambers and blood vessels by pictures taken by x-rays. This technology exposes patients to radiation. With this study protocol the investigators will use MRI technology to take real-time pictures to navigate catheters throughout heart chambers. MRI uses electromagnetic energy; therefore, it does not expose participants to radiation energy.

Conditions

Eligibility

Eligible Ages
All ages
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Undergoing a medically necessary cardiovascular catheterization

Exclusion Criteria

  • Cardiovascular instability including hemodynamic instability (such as requiring significant vasoactive infusion support) or mechanical hemodynamic support.
  • Women who are pregnant
  • Women who are nursing and who do not plan to discard breast milk for 24 hours
  • Patients with a contraindication to MRI scanning will be excluded. These contraindications include patients with the following devices:
  • Central nervous system aneurysm clips
  • Implanted neural stimulator
  • Implanted cardiac pacemaker or defibrillator which are not MR safe or MR conditional according to the manufacturer
  • Cochlear implant
  • Ocular foreign body (e.g. metal shavings)
  • Implanted Insulin pump
  • Metal shrapnel or bullet

Exclusion criteria for Gadolinium (contrast agent)

1. Renal disease with estimated glomerular filtration rate < 30 ml/min/1.73 m2 body surface area

Study Design

Phase
Phase 1
Study Type
Interventional
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
MRI guided cardiac catheterization
Magnetic resonance imaging will be used to guide cardiac catheterization procedures.
  • Procedure: MRI guided cardiac catheterization
    Magnetic resonance imaging will be used to guide cardiac catheterization procedures whenever possible to avoid or minimize x-ray radiation exposure.
  • Device: Magnetic resonance imaging

Recruiting Locations

Children's National and nearby locations

Children's National Health System
Washington, District of Columbia 20010
Contact:
Joshua Kanter, MD
202-476-2020
jkanter@childrensnational.org

More Details

NCT ID
NCT02739087
Status
Recruiting
Sponsor
Joshua Kanter

Study Contact

Joshua Kanter, MD
202-476-2020
jkanter@childrensnational.org

Detailed Description

Participants undergo general anesthesia, and vascular access is obtained in the x-ray catheterization lab. Next the participant is transferred into the MRI scanner where a focused MRI examination is performed. Catheters are then guided into the heart chambers using real-time MRI guidance to perform conventional cardiac catheterization steps. If time allows, additional research MRI is performed before the participant is returned to the x-ray catheterization lab. If any MRI guided catheterization steps are unsuccessful, the clinically indicated step is performed after the participant returns to the x-ray catheterization lab using conventional x-ray guided pictures.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.