MRI-Guided Catheterization for Heart Disease

Overseen By Robert J Lederman, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Disqualifiers: Cardiovascular instability, Pregnancy, MRI incompatibility, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if using a guidewire during MRI heart procedures is safe and effective. The guidewire positions the catheter, a thin tube, inside the heart, potentially speeding up the procedure. The trial focuses on using special MRI settings to prevent the guidewire from heating, a common concern. Adults whose doctors recommend a right heart catheterization might be suitable candidates for this trial. As an unphased study, this trial offers patients the chance to contribute to innovative research that could enhance the safety and efficiency of heart procedures.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators or your doctor for guidance.

What prior data suggests that this MRI-guided catheterization is safe for heart procedures?

Research has shown that using MRI to guide heart procedures is generally safe for both adults and children. Studies have found that this method does not cause significant harm. Special MRI settings prevent the guidewires from overheating, addressing a common concern.

In past studies, patients did not experience serious problems during these procedures, suggesting that the treatment is well-tolerated. Overall, the evidence supports MRI-guided catheterization as a safe option for heart patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about MRI-guided catheterization for heart disease because it offers a novel approach to heart procedures. Unlike traditional catheterization methods that rely on X-ray imaging, this technique uses MRI, which provides a more detailed and clearer view of the heart's structures without radiation exposure. This could lead to more precise interventions and better outcomes for patients with heart disease. Additionally, MRI guidance may reduce the risk of complications associated with traditional methods, making it a potentially safer option for patients.

What evidence suggests that MRI-guided catheterization is effective for heart disease?

In this trial, participants will undergo MRI-guided heart catheterization. Earlier studies have shown promise for this method, as it provides a clearer view of the heart without the radiation risks of traditional x-rays. This technique helps doctors see the heart chambers more clearly, aiding in diagnosing and treating heart conditions. Research indicates that using special low-energy MRI settings with guidewires is likely safe, avoiding the heating problems usually associated with MRI. Early results suggest this technique might also shorten procedure time. Overall, MRI-guided catheterization could improve outcomes for patients needing heart catheterization. ^{2 3 5 6 7}

Who Is on the Research Team?

Robert J Lederman, M.D.

Principal Investigator

National Heart, Lung, and Blood Institute (NHLBI)

Are You a Good Fit for This Trial?

This trial is for adults over 18 who need a heart catheterization, which is a procedure to check heart function. Participants must not be pregnant or nursing, have severe heart valve issues, unstable heart conditions like ongoing attacks or failure, and can't have certain metal implants or allergies to MRI contrast agents.

Inclusion Criteria

I am scheduled for a heart catheterization procedure.

Exclusion Criteria

I have a severe narrowing of my heart's aortic valve.

I am not pregnant or nursing.

You cannot have a magnetic resonance imaging (MRI) scan.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Procedure

Participants undergo MRI fluoroscopy catheterization using guidewires to measure heart pressures and visualize heart chambers.

2 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure.

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MRI Heart guidewire catheterization
• MRI Right and Left Heart guidewire catheterization

Trial Overview The study tests if using special guidewires during an MRI-guided heart catheterization is safe with low energy settings that prevent the wires from heating up. This could make the procedure quicker and reduce time in the MRI machine.

How Is the Trial Designed?

Group I: 1 Experimental Treatment 1 Intervention

Open label

MRI Heart guidewire catheterization is already approved in United States, European Union for the following indications:

Approved in United States as MRI-guided heart catheterization for:

• Diagnostic heart procedure for measuring pressures and imaging blood flow through heart chambers

Approved in European Union as MRI-guided heart catheterization for:

• Diagnostic heart procedure for measuring pressures and imaging blood flow through heart chambers

Who Is Running the Clinical Trial?

National Heart, Lung, and Blood Institute (NHLBI)

Lead Sponsor

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

Three main strategies for visualizing MR-dedicated guidewires and catheters have been identified: active tracking, locally induced field inhomogeneity, and passive susceptibility-based tracking, each with its own advantages and disadvantages.

The article discusses the development of these MR tracking techniques, including scan methods and post-processing tools, highlighting their potential to improve the accuracy and effectiveness of medical procedures involving guidewires and catheters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventional MR: vascular applications. Smits, HF., Bos, C., van der Weide, R., et al.[2020]

A new clinical-grade MRI guidewire with an internal fiberoptic temperature probe allows for real-time monitoring of temperature during catheterization, enhancing safety by detecting potential overheating without affecting the guidewire's flexibility or visibility.

In tests, the guidewire showed negligible heating under normal MRI operating conditions, with only a slight temperature increase observed during high RF power mode, indicating it can be safely used in interventional cardiovascular procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI active guidewire with an embedded temperature probe and providing a distinct tip signal to enhance clinical safety. Sonmez, M., Saikus, CE., Bell, JA., et al.[2021]

MRI guidance for coronary interventions offers significant advantages over traditional x-ray angiography, including the use of nonionizing radiation and the ability to assess both anatomy and function of the coronary arteries in three dimensions.

Recent studies have demonstrated the feasibility of real-time coronary MR angiography with high spatial and temporal resolution, suggesting that MRI could become a valuable tool for diagnosing and treating coronary artery disease in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging-guided coronary interventions. Tsekos, NV., Atalar, E., Li, D., et al.[2007]

A new MR-compatible guide wire was successfully used in a preclinical study involving 20 cardiac interventions in swine, demonstrating its safety and efficacy for procedures like balloon dilation of heart valves.

The first two human cases using this MR-guided technique were successful in relieving valvar pulmonary stenosis in both a child and an adult, with no complications reported, suggesting a promising future for MR-guided cardiac interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance-guided cardiac interventions using magnetic resonance-compatible devices: a preclinical study and first-in-man congenital interventions. Tzifa, A., Krombach, GA., Krämer, N., et al.[2012]

In a preclinical study involving 13 pigs, real-time MRI (rtMRI) successfully guided stenting procedures for aortic coarctation, demonstrating its safety and feasibility using commercially available catheter devices.

The use of 'active' guidewires with MRI antennas significantly improved device visualization and reduced procedure time compared to standard guidewires, while rtMRI allowed for immediate identification of complications like aortic rupture.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time magnetic resonance imaging-guided stenting of aortic coarctation with commercially available catheter devices in Swine. Raval, AN., Telep, JD., Guttman, MA., et al.[2021]

MRI-guided cardiac catheterisation is a safe and practical alternative to traditional fluoroscopic methods, allowing for better visualization of soft tissues and lower radiation exposure for patients.

In a study of 16 cases, MRI guidance provided valuable physiological information and improved the planning and execution of procedures like balloon angioplasty and radiofrequency ablation, suggesting it could become the preferred method for treating congenital heart disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac catheterisation guided by MRI in children and adults with congenital heart disease. Razavi, R., Hill, DL., Keevil, SF., et al.[2022]

This study tested the use of magnetic resonance imaging (MRI) for real-time visualization during coronary catheterization, using loopless antennas as guidewires and guiding catheters in six healthy dogs.

The results showed that MRI could successfully provide simultaneous images of the guidewire, guiding catheter, and chest anatomy, indicating a promising step towards safer and more effective MRI-guided coronary procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward MRI-guided coronary catheterization: visualization of guiding catheters, guidewires, and anatomy in real time. Serfaty, JM., Yang, X., Aksit, P., et al.[2019]

MRI catheterization is a new, radiation-free procedure that allows for simultaneous invasive hemodynamic assessment and MRI functional imaging, improving the diagnosis and management of complex cardiopulmonary diseases.

This innovative technique is already being used in specialized centers in the U.S. and Europe, and advancements in medical device design are expected to expand its applications to interventional procedures in the near future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI catheterization in cardiopulmonary disease. Rogers, T., Ratnayaka, K., Lederman, RJ.[2021]

MRI-guided cardiac catheterization offers a safer alternative to traditional x-ray methods by reducing radiation exposure, particularly important for children who are more vulnerable to cumulative radiation effects.

Recent advancements in MRI technology, including improved catheter tracking and the development of MRI-compatible guidewires, have enhanced the feasibility and effectiveness of MRI-guided interventions, paving the way for broader clinical applications in diagnosing and treating congenital heart disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MR-guided Cardiac Interventions. Pushparajah, K., Chubb, H., Razavi, R.[2019]

The novel MRI-visible glass-fiber epoxy-based guidewire demonstrated excellent safety during 3T MRI procedures, with guidewire tip heating not exceeding 0.35°C, indicating minimal risk of thermal injury.

Real-time MRI-guided cardiovascular catheterization was successfully performed in both healthy and infarcted porcine models, with an average procedure time of 4:32, showcasing the guidewire's effective visualization and navigation capabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time 3T MRI-guided cardiovascular catheterization in a porcine model using a glass-fiber epoxy-based guidewire. Li, X., Perotti, LE., Martinez, JA., et al.[2020]

Citations

1. patlynk.com patlynk.com/trial/NCT03152773

Heart Catheterization Using Magnetic Resonance Imaging ... Guidewires will help move the heart catheter through the different heart chambers. Guidewires are usually considered unsafe during MRI because MRI can cause a ...

2. withpower.com withpower.com/trial/phase-heart-defects-congenital-7-2017-75a88

MRI-Guided Catheterization for Heart Disease Yes, MRI-guided heart catheterization is a promising treatment for heart disease. It offers better visualization of soft tissues and heart structures without ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8979923/

MRI-Guided Cardiac Catheterization in Congenital Heart ... This review focuses on the benefits and background of real-time magnetic resonance imaging (MRI)-guided cardiac catheterization, guidance on starting a ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03152773

Heart Catheterization Using Magnetic Resonance Imaging ... The catheters are guided by MRI fluoroscopy into the chambers of the heart and vessels. The guidewire will help position the catheter. Detailed Description.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1097664725000201

Feasibility of magnetic resonance imaging-guided cardiac ... The purpose of this study was to test the feasibility of real-time MRI-guided right and left heart catheterization (R&LHC) as well as angioplasty and stenting ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8247035/

MRI for Guided Right and Left Heart Cardiac Catheterization Data Conclusion. MRI‐guided catheterizations were carried out safely and is feasible in children and adults with CHD. The pSAT sequence offered ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1875213624000378

Feasibility, safety and diagnostic yield of interventional ... CMR-RHC seems to be a feasible and safe procedure that can be used in routine daily practice in consecutive adults with an impactful clinical yield.