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. ]
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