Radiation-Free Heart Catheterization Using MRI
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ClinicalTrials.gov Identifier: NCT02739087 |
Recruitment Status :
Active, not recruiting
First Posted : April 14, 2016
Last Update Posted : April 6, 2022
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Condition or disease | Intervention/treatment | Phase |
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Aortic Coarctation Cardiomyopathy Atrial Septal Defect Aortic Stenosis Post Heart Transplant Catheter Procedure Patent Ductus Arteriosus | Procedure: MRI guided cardiac catheterization Device: Magnetic resonance imaging | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Radiation-Free Heart Catheterization Using MRI |
Study Start Date : | March 2015 |
Estimated Primary Completion Date : | December 2024 |
Estimated Study Completion Date : | December 2024 |

Arm | Intervention/treatment |
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Experimental: MRI guided cardiac catheterization
Magnetic resonance imaging will be used to guide cardiac catheterization procedures.
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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 |
- 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.
- 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.

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | 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
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02739087
United States, District of Columbia | |
Children's National Health System | |
Washington, District of Columbia, United States, 20010 |
Principal Investigator: | Joshua Kanter, MD | Children's National Research Institute |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Joshua Kanter, MD, Children's National Research Institute |
ClinicalTrials.gov Identifier: | NCT02739087 |
Other Study ID Numbers: |
3860 Internal Bridge funding ( Other Identifier: Children's Research Institute, Children's National ) |
First Posted: | April 14, 2016 Key Record Dates |
Last Update Posted: | April 6, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
radiation free cardiac catheterization |
Cardiomyopathies Aortic Valve Stenosis Ductus Arteriosus, Patent Aortic Coarctation Heart Septal Defects, Atrial Heart Diseases Cardiovascular Diseases |
Aortic Valve Disease Heart Valve Diseases Ventricular Outflow Obstruction Heart Defects, Congenital Cardiovascular Abnormalities Congenital Abnormalities Heart Septal Defects |