Suspended

MRI Fluoroscopy in Heart Catheterization with Passive Guidewires

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Study AimThis study tests the safety and feasibility of using MRI fluoroscopy during heart catheterization with passive guidewires to gather important heart and vessel data.
What is being tested

MRI Heart guidewire catheterization

Procedure
Who is being recruted

Pulmonary Artery Hypertension

+ Congenital Heart Disease
+ Structural Heart Disease
Over 18 Years

See all eligibility criteria

How is the trial designed

Diagnostic Study

Interventional
Study Start: August 2017

See protocol details

Summary

Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: September 3, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: August 2, 2017Actual date on which the first participant was enrolled.

This study investigates a new way to perform heart catheterization using MRI fluoroscopy instead of traditional X-ray guidance. Heart catheterization helps doctors measure the pressure inside the heart, but using X-rays can expose patients to radiation and doesn't show soft tissues clearly. This research is particularly important for people with heart issues because it explores a safer method that reduces radiation exposure while still providing detailed images. The study focuses on using special guidewires that won’t heat up during MRI, making it possible to perform the procedure safely. Participants in this study will undergo heart catheterization using MRI technology, where guidewires will help steer the catheters through the veins and arteries of the heart. The process involves using low-energy MRI techniques to guide the catheters without the need for X-rays. The study will evaluate how well this technique works by measuring heart function and responses during the procedure. By testing the safety and effectiveness of this method, researchers aim to refine the technique, which could eventually lead to new treatments for heart conditions without surgery.

Official TitleHeart Catheterization Using Magnetic Resonance Imaging (MRI) Fluoroscopy and Passive Guidewires 
Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: September 3, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
22 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Diagnostic Study
Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Pulmonary Artery Hypertension
Congenital Heart Disease
Structural Heart Disease
Criteria

* INCLUSION CRITERIA: * Age greater than or equal to 18 years old * Undergoing medically necessary diagnostic or interventional right cardiovascular catheterization, alone or in combination with a left cardiovascular catheterization EXCLUSION CRITERIA: * Cardiovascular instability including ongoing acute myocardial infarction, refractory angina or ischemia, and decompensated congestive heart failure. * Women who are pregnant or nursing * Unable to undergo magnetic resonance imaging * Cerebral aneurysm clip * Neural stimulator (e.g. TENS-Unit) * Any type of ear implant * Ocular foreign body (e.g. metal shavings) * Metal shrapnel or bullet. * Any implanted device (e.g. insulin pump, drug infusion device), unless it is labeled safe for MRI EXCLUSION CRITERIA FOR GADOLINIUM-BASED CONTRAST AGENTS: Renal excretory dysfunction, estimated glomerular filtration rate \< 30 mL/min/1.73m2 body surface area according to the Modification of Diet in Renal Disease criteria Glomerular filtration rate will be estimated using the CKD-EPI equation: eGFR = 141 x (minimum of (S(Cr)/k, 1)\^alpha x (maximum of (S(Cr) /k, 1))\^-1.209 x 0.993\^Age x 1.018 (if female) x 1.159 (if black) Where S(Cr) = serum creatinine alpha = -0.329 for females and -0.411 for males k = 0.7 for females and 0.9 for males Subjects meeting this exclusion criterion may still be included in the study but may not be exposed to gadolinium-based contrast agents. Exclusion criteria for ferumoxytol: * Allergy to ferumoxytol or to mannitol excipient * Does not wish to be exposed to ferumoxytol Exclusion criteria for MRI left heart catheterization: -Severe aortic valve stenosis

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Open label
Study Objectives
Primary Objectives

Acquisition of hemodynamic and saturation data from targeted chambers and vessels.
Secondary Objectives

Conspicuity of Glidewires during MRI fluoroscopy catheterization

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
National Institutes of Health Clinical CenterBethesda, United StatesSee the location
SuspendedOne Study Center