Right Heart Catheterization Using Magnetic Resonance Imaging Fluoroscopy and Passive Guidewires
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|ClinicalTrials.gov Identifier: NCT03152773|
Recruitment Status : Recruiting
First Posted : May 15, 2017
Last Update Posted : August 9, 2018
Right heart catheterization tests heart pressures and flows. Magnetic resonance imaging (MRI) fluoroscopy shows pictures of the heart that doctors can watch while they work. Researchers want to test this procedure with a tool called a guidewire. This will help position the heart catheter into different heart chambers. Guidewires are usually considered unsafe during MRI because MRI can make them hot inside the body. Researchers have created special MRI settings that stop one guidewire from getting hot. Using this guidewire during MRI may make improve catheterization.
To test if certain MRI settings make it safe to use a guidewire during MRI fluoroscopy.
Adults 18 and older whose doctors have recommended right heart catheterization.
Researchers will screen participants by reviewing their lab results and questionnaire answers.
Participants will give 4 blood samples.
Participants will be sedated. They will have a tube (catheter) placed in the groin, arm, or neck if they don t already have one.
Patches on the skin will monitor heart rhythm. Special antennas, covered in pads, will be placed against the body.
Participants will lie flat on a table that slides in and out of the MRI scanner as it makes pictures. Participants will get earplugs for the loud knocking noise. They can talk on an intercom. They will be inside the scanner for up to 2 hours. They can ask to stop at any time.
For right heart catheterization, catheters will be inserted through the tubes already in place. The catheters are guided by MRI fluoroscopy into the chambers of the heart and vessels. The guidewire will help position the catheter.
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Artery Hypertension Congenital Heart Disease||Device: MRI Right Heart guidewire catheterization||Phase 1 Phase 2|
Heart catheterization is a minimally invasive procedure to measure pressure into specific heart cavities. Heart catheterization usually uses X-ray guidance, which involves radiation exposure and which fails to visualize soft tissue. For several years, real-time magnetic resonance imaging (MRI) fluoroscopy has been the standard technique to guide right heart catheterization at the NIH clinical center. Guidewires are standard tools used to steer catheters through the body and heart.
Guidewires have not been used during MRI fluoroscopy catheterization because of the risk of heating. We have developed MRI techniques that do not risk heating using one specific commercial guidewire. In this protocol we will use this new lowenergy real-time MRI fluoroscopy technique to enable use of guidewires during otherwise standard MRI catheterization of the right side of the heart through veins.
If the initial phases of the protocol prove successful, in subsequent amendments we will use this technique to position catheters in the left ventricle through arteries.
If successful, this will enable future testing of devices for adult and pediatric MRI-fluoroscopy catheterization, which may lead to new non-surgical treatments of cardiovascular disease.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Right Heart Catheterization Using MRI Fluoroscopy and Passive Guidewires|
|Actual Study Start Date :||August 2, 2017|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Device: MRI Right Heart guidewire catheterization
To conduct right heart guidewire catheterization using real-time MRI fluoroscopy in human research subjects already undergoing medically necessary right heart catheterization. We will use only passive MRI-compatible catheters and a specific guidewire shown to be safe under specific conditions. Under the conditions of use, the guidewire is not susceptible to heating.
- To test the safety of performing right heart catheterization with a Terumo Glidewire guided by low-SAR MRI fluoroscopy [ Time Frame: 2 hours ]acquisition of hemodynamic and saturation data from targeted chambers and vessels.
- To test in vivo human conspicuity of the glidewire using off-resonance MR image reconstruction. [ Time Frame: 2 hours ]Conspicuity of Glidewires during MRI fluoroscopy catheterization
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03152773
|Contact: Annette Stine, R.N.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Robert J Lederman, M.D.||National Heart, Lung, and Blood Institute (NHLBI)|