Radiation-Free Heart Catheterization Using MRI
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02739087|
Recruitment Status : Active, not recruiting
First Posted : April 14, 2016
Last Update Posted : April 6, 2022
|Condition or disease||Intervention/treatment||Phase|
|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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
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|