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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

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 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

Trial Design

1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment1 Intervention
Open label

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)Lead Sponsor
3,889 Previous Clinical Trials
47,834,107 Total Patients Enrolled
2 Trials studying Structural Heart Disease
1,150 Patients Enrolled for Structural Heart Disease
Robert J Lederman, M.D.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)
13 Previous Clinical Trials
805 Total Patients Enrolled

Media Library

MRI Heart guidewire catheterization (Passive Guidewire) Clinical Trial Eligibility Overview. Trial Name: NCT03152773 — N/A
Structural Heart Disease Research Study Groups: 1
Structural Heart Disease Clinical Trial 2023: MRI Heart guidewire catheterization Highlights & Side Effects. Trial Name: NCT03152773 — N/A
MRI Heart guidewire catheterization (Passive Guidewire) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03152773 — N/A
~3 spots leftby Dec 2024
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