Clinical Trial: Radiation-Free Heart Catheterization Using MRI

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Radiation-Free Heart Catheterization Using MRI

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Joshua Kanter

Current Primary Outcome: Test the feasibility of navigating catheters into right heart structures using real-time MRI [ Time Frame: At the end of each catheterization procedure through study completion,up to 5 years. ]

Heart catheterization usually uses X-ray guidance. Using commercially available MRI-compatible catheters, the right heart catheterization procedure will be done using real-time magnetic resonance imaging (MRI). MRI guidance does not use X-ray radiation.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of participants whose MRI cardiac catheterization procedure was prematurely terminated [ Time Frame: At the end of each catheterization procedure through study completion,up to 5 years ]

    Premature termination will occur under the following circumstances:

    • Hemodynamic or other clinical instability
    • Technical failure of catheter procedure such as being unable to navigate the catheters to the heart chamber
    • Equipment malfunction
    • Any other circumstance that in the opinion of the Principal Investigator poses hazard to the research subject
  • Measurement of radiation exposure [ Time Frame: End of study, 5 years. ]
    Comparison of radiation exposure in this cohort of subjects to historical controls undergoing matched invasive cardiology procedure at CNMC.


Original Secondary Outcome: Same as current

Information By: Children's Research Institute

Dates:
Date Received: February 17, 2016
Date Started: March 2015
Date Completion: March 2025
Last Updated: October 31, 2016
Last Verified: October 2016