Suspended

MRI Fluoroscopy in Heart Catheterization with Passive Guidewires

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Study Aim

This 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

Congenital Abnormalities+7

+ Cardiovascular Diseases

+ Heart Defects, Congenital

From 18 to 100 Years
+15 Eligibility Criteria
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: March 21, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 2, 2017

Actual 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
NCT03152773
Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: March 21, 2026
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 enrolled

Total 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.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 100 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Congenital AbnormalitiesCardiovascular DiseasesHeart Defects, CongenitalHeart DiseasesHypertension, PulmonaryLung DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesRespiratory Tract DiseasesCardiovascular AbnormalitiesFamilial Primary Pulmonary Hypertension

Criteria

2 inclusion criteria required to participate
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

13 exclusion criteria prevent from participating
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

Unable to undergo magnetic resonance imaging

Cerebral aneurysm clip

Neural stimulator (e.g. TENS-Unit)

Show More Criteria

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

Secondary Objectives

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 Center

Bethesda, United StatesOpen National Institutes of Health Clinical Center in Google Maps
SuspendedOne Study Center