An interventional study of MRI guided cardiac catheterization and Magnetic resonance imaging in Aortic Coarctation, Cardiomyopathy and Atrial Septal Defect, sponsored by Joshua Kanter. Active, not recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2024-02-06.
Sponsored by Joshua Kanter · Not applicable, Interventional, and Diagnostic
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.
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.
49 studies on the registry are indexed under Aortic Coarctation; 16 are open to participants now.
This study's planned enrollment of 50 is above the median of 45 across 19 interventional studies indexed under Aortic Coarctation.
Browse Aortic Coarctation studies →Joshua Kanter is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with a to MRI scanning will be excluded. These contraindications include patients with the following devices:
Exclusion criteria for Gadolinium (contrast agent)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Magnetic resonance imaging will be used to guide cardiac catheterization procedures.
Procedure: MRI guided cardiac catheterization · Device: Magnetic resonance imaging
Magnetic resonance imaging will be used to guide cardiac catheterization procedures whenever possible to avoid or minimize x-ray radiation exposure.
Test the feasibility of navigating catheters into right heart structures using real-time MRI
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.
Time frame: At the end of each catheterization procedure through study completion,up to 5 years.
Number of participants whose MRI cardiac catheterization procedure was prematurely terminated
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
Time frame: At the end of each catheterization procedure through study completion,up to 5 years
Measurement of radiation exposure
Comparison of radiation exposure in this cohort of subjects to historical controls undergoing matched invasive cardiology procedure at CNMC.
Time frame: End of study, 5 years.
Plan to share: No
The record gives a start of Mar 2015, a primary completion of Dec 2024 and a completion of Dec 2024. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Joshua Kanter