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Passive Guidewire

MRI-Guided Catheterization for Heart Disease

N/A

Recruiting

Led By Robert J Lederman, M.D.

Research Sponsored by National Heart, Lung, and Blood Institute (NHLBI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Undergoing medically necessary diagnostic or interventional right cardiovascular catheterization, alone or in combination with a left cardiovascular catheterization

Age greater than or equal to 18 years old

Must not have

Severe aortic valve stenosis

Women who are pregnant or nursing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if special MRI settings make it safe to use a guidewire during MRI fluoroscopy. Researchers will compare the safety of the special MRI settings with the safety of standard MRI settings.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort from lying still inside the MRI scanner for up to two hours, risks associated with sedation and catheter insertion such as bleeding or infection at the site of entry, and possible allergic reactions to materials used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for a heart catheterization procedure.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am not pregnant or nursing.

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I do not have unstable heart conditions like ongoing heart attacks or severe heart failure.

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I have a foreign object, like metal, in my eye.

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My kidney function is significantly reduced.

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I do not want to receive ferumoxytol treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The principal objective of this protocol is to test the safety and feasibility of MRI fluoroscopy catheter navigation using 0.035 guidewires during left and right heart catheterization guided by low-SAR MRI pulse sequences

Secondary study objectives

Additional objectives are to test and enhanced MRI as an adjunct to routine hemodynamic cardiac catheterization