Pulmonary Artery HypertensionNCT03152773
Heart Catheterization Using Magnetic Resonance Imaging (MRI) Fluoroscopy and Passive Guidewires
A study testing MRI Heart guidewire catheterization in people with Pulmonary Artery Hypertension and Congenital Heart Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
Background: A heart catheterization is a diagnostic heart procedure used to measure pressures and take pictures of the blood flow through the heart chambers. Magnetic resonance imaging (MRI) fluoroscopy shows continuous pictures of the heart chambers that doctors can watch while they work. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pulmonary Artery Hypertension, Congenital Heart Disease, Structural Heart Disease
- What is being tested?
- MRI Heart guidewire catheterization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2017to 14 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
- 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.
- Allergy to ferumoxytol or to mannitol excipient
- Does not wish to be exposed to ferumoxytol
- -Severe aortic valve stenosis
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Background:
A heart catheterization is a diagnostic heart procedure used to measure pressures and take pictures of the blood flow through the heart chambers. Magnetic resonance imaging (MRI) fluoroscopy shows continuous pictures of the heart chambers that doctors can watch while they work. Researchers want to test this procedure with catheterization tools routinely used in x-ray catheterization called guidewires. Guidewires will help move the heart catheter through the different heart chambers. Guidewires are usually considered unsafe during MRI because MRI can cause a guidewire to heat while inside the blood vessels and heart. Researchers are testing special low energy MRI settings that allow certain guidewires to be used during MRI catheterization without heating. Using these guidewires during MRI may help to decrease the amount of time you are in the MRI scanner, and the overall time the MRI catheterization procedure takes.
Read more
Objectives:
To test if certain MRI settings make it safe to use a guidewire during MRI fluoroscopy.
Eligibility:
Adults 18 and older whose doctors have recommended right heart catheterization.
Design:
Researchers will screen participants by reviewing their lab results and questionnaire answers.
Participants may give 4 blood samples.
Participants will be sedated. They will have a tube (catheter) placed in the groin, arm, or neck if they don t already have one.
Patches on the skin will monitor heart rhythm. Special antennas, covered in pads, will be placed against the body.
Participants will lie flat on a table that slides in and out of the MRI scanner as it makes pictures. Participants will get earplugs for the loud knocking noise. They can talk on an intercom. They will be inside the scanner for up to 2 hours. They can ask to stop at any time.
During a heart catheterization, catheters will be inserted through the tubes already in place. The catheters are guided by MRI fluoroscopy into the chambers of the heart and vessels. The guidewire will help position the catheter.
Read the detailed description
Heart catheterization is a minimally invasive procedure to measure pressure into specific heart cavities. Heart catheterization usually uses X-ray guidance, which involves radiation exposure, and which fails to visualize soft tissue. For several years, real-time magnetic resonance imaging (MRI) fluoroscopy has been the standard technique to guide right heart catheterization at the NIH clinical center.
Guidewires are standard tools used to steer catheters through the body and heart. Guidewires have not been used during MRI fluoroscopy catheterization because of the risk of heating. We have developed MRI techniques that do not risk heating using specific commercial guidewires. In this protocol we will use this new low-energy real-time MRI fluoroscopy technique to enable use of guidewires during otherwise standard MRI catheterization of the right side of the heart through veins, and of the left side of the heart through the aorta.
In the second phase of the protocol, we will begin performing systematic MRI guidewire heart catheterization without X-ray whenever possible. We will assess the heart s response to hemodynamic provocation during MRI catheterization tailored to the patient s problem. We will use this protocol to further refine the technique.
This will enable future testing of devices for adult and pediatric MRI-fluoroscopy catheterization, which may lead to new non-surgical treatments of cardiovascular disease.
- Being tested
- MRI Heart guidewire catheterization
- Keywords
- MRI Catheterization, Real-time MRI
- Medical subject headings
- Familial Primary Pulmonary Hypertension, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI Heart guidewire catheterizationDiagnostic test
To conduct left and right heart guidewire catheterization using real-time MRI fluoroscopy in human research subjects already undergoing medically necessary left and right heart catheterization. We will use only passive MRI-compatible catheters and a specific guidewire shown to be safe under specific conditions. Under the conditions of use, the guidewire is not susceptible to heating.
| Study group | Role | What they receive |
|---|---|---|
| Participants Undergoing Clinically Indicated Cardiac Catheterization | Experimental | Participants undergoing clinically indicated right heart catheterization will undergo MRI-guided cardiac guidewire catheterization. The procedure will involve left and right heart guidewire catheterization using real-time MRI fluoroscopy in human research participants who are already undergoing medically necessary cardiac catheterization. Receives: Diagnostic Test: MRI Heart guidewire catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Procedure-Related Adverse Events During Low-SAR MRI-Guided Catheterization
Number of participants with any procedure-related adverse event during MRI-guided cardiac catheterization using passive MRI-compatible catheters and the specified guidewire under defined low-SAR conditions using Common Terminology Criteria for Adverse Events (CTCAE) grading. Events included clinically significant arrhythmia, hemodynamic instability requiring treatment, vascular injury, cardiac perforation/tamponade, device-related heating or burn, or other intervention-related complication.
The CTCAE employs a 5-point scale to standardize the grading of adverse events from mild to fatal:
- Grade 1 (Mild): Asymptomatic or mild symptoms; no intervention required.
- Grade 2 (Moderate): Local/noninvasive intervention needed; limits instrumental ADL.
- Grade 3 (Severe): Severe/medically significant; hospitalization or prolongation; limits self-care ADL.
- Grade 4 (Life-threatening): Urgent intervention required.
- Grade 5 (Fatal): Death related to the adverse event
Measured: During procedure through discharge, up to 4 hours after the procedure
Secondary outcomes (1)
Number of Participants Who Completed the MRI-guided Portion of Cardiac Catheterization Without Life-threatening Hemodynamic Instability
Life-threatening hemodynamic instability was defined as instability requiring defibrillation, cardioversion, emergency pacing, or pericardiocentesis for cardiac tamponade. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE).
The CTCAE employs a 5-point scale to standardize the grading of adverse events from mild to fatal:
- Grade 1 (Mild): Asymptomatic or mild symptoms; no intervention required.
- Grade 2 (Moderate): Local/noninvasive intervention needed; limits instrumental ADL.
- Grade 3 (Severe): Severe/medically significant; hospitalization or prolongation; limits self-care ADL.
- Grade 4 (Life-threatening): Urgent intervention required.
- Grade 5 (Fatal): Death related to the adverse event
Measured: From start of MRI-guided catheterization through completion of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start2 Aug 2017
- Primary completion14 Dec 2021
- Study completion14 Dec 2021
Why it stopped: Due to the clinical hold, the study was terminated prior to completion, and the Sponsor subsequently determined that the study would not be reopened.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Artery HypertensionStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Robert J Lederman, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03152773
- Sponsor's protocol ID
- 170095
- Other IDs
- 17-H-0095
- Status last verified
- Jun 2026
- First submitted
- 12 May 2017
- Last updated
- 15 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The authors are willing to share de-identified subject data upon reasonable request
Publications
Campbell-Washburn AE, Rogers T, Stine AM, Khan JM, Ramasawmy R, Schenke WH, McGuirt DR, Mazal JR, Grant LP, Grant EK, Herzka DA, Lederman RJ. Right heart catheterization using metallic guidewires and low SAR cardiovascular magnetic resonance fluoroscopy at 1.5 Tesla: first in human experience. J Cardiovasc Magn Reson. 2018 Jun 21;20(1):41. doi: 10.1186/s12968-018-0458-7.
PubMed 29925397
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Catheterization Using Magnetic Resonance Imaging (MRI) Fluoroscopy and Passive Guidewires
- ClinicalTrials.gov ID
- NCT03152773
- Acronym / sponsor ID
- 170095
- Keywords
- MRI Catheterization, Real-time MRI
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the clinical hold, the study was terminated prior to completion, and the Sponsor subsequently determined that the study would not be reopened.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 2 Aug 2017 (actual)
- Primary completion
- 14 Dec 2021 (actual)
- Study completion
- 14 Dec 2021 (actual)
- First posted
- 15 May 2017 (actual)
- Results
- Posted 15 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
A heart catheterization is a diagnostic heart procedure used to measure pressures and take pictures of the blood flow through the heart chambers. Magnetic resonance imaging (MRI) fluoroscopy shows continuous pictures of the heart chambers that doctors can watch while they work. Researchers want to test this procedure with catheterization tools routinely used in x-ray catheterization called guidewires. Guidewires will help move the heart catheter through the different heart chambers. Guidewires are usually considered unsafe during MRI because MRI can cause a guidewire to heat while inside the blood vessels and heart. Researchers are testing special low energy MRI settings that allow certain guidewires to be used during MRI catheterization without heating. Using these guidewires during MRI may help to decrease the amount of time you are in the MRI scanner, and the overall time the MRI catheterization procedure takes.
Objectives:
To test if certain MRI settings make it safe to use a guidewire during MRI fluoroscopy.
Eligibility:
Adults 18 and older whose doctors have recommended right heart catheterization.
Design:
Researchers will screen participants by reviewing their lab results and questionnaire answers.
Participants may give 4 blood samples.
Participants will be sedated. They will have a tube (catheter) placed in the groin, arm, or neck if they don t already have one.
Patches on the skin will monitor heart rhythm. Special antennas, covered in pads, will be placed against the body.
Participants will lie flat on a table that slides in and out of the MRI scanner as it makes pictures. Participants will get earplugs for the loud knocking noise. They can talk on an intercom. They will be inside the scanner for up to 2 hours. They can ask to stop at any time.
During a heart catheterization, catheters will be inserted through the tubes already in place. The catheters are guided by MRI fluoroscopy into the chambers of the heart and vessels. The guidewire will help position the catheter.
Detailed description
Heart catheterization is a minimally invasive procedure to measure pressure into specific heart cavities. Heart catheterization usually uses X-ray guidance, which involves radiation exposure, and which fails to visualize soft tissue. For several years, real-time magnetic resonance imaging (MRI) fluoroscopy has been the standard technique to guide right heart catheterization at the NIH clinical center.
Guidewires are standard tools used to steer catheters through the body and heart. Guidewires have not been used during MRI fluoroscopy catheterization because of the risk of heating. We have developed MRI techniques that do not risk heating using specific commercial guidewires. In this protocol we will use this new low-energy real-time MRI fluoroscopy technique to enable use of guidewires during otherwise standard MRI catheterization of the right side of the heart through veins, and of the left side of the heart through the aorta.
In the second phase of the protocol, we will begin performing systematic MRI guidewire heart catheterization without X-ray whenever possible. We will assess the heart s response to hemodynamic provocation during MRI catheterization tailored to the patient s problem. We will use this protocol to further refine the technique.
This will enable future testing of devices for adult and pediatric MRI-fluoroscopy catheterization, which may lead to new non-surgical treatments of cardiovascular disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants Undergoing Clinically Indicated Cardiac Catheterization | Experimental | Diagnostic Test: MRI Heart guidewire catheterizationParticipants undergoing clinically indicated right heart catheterization will undergo MRI-guided cardiac guidewire catheterization. The procedure will involve left and right heart guidewire catheterization using real-time MRI fluoroscopy in human research participants who are already undergoing medically necessary cardiac catheterization. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (20 listed)
- 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
- 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
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI Heart guidewire catheterizationTo conduct left and right heart guidewire catheterization using real-time MRI fluoroscopy in human research subjects already undergoing medically necessary left and right heart catheterization. We will use only passive MRI-compatible catheters and a specific guidewire shown to be safe under specific conditions. Under the conditions of use, the guidewire is not susceptible to heating. | Diagnostic test | Participants Undergoing Clinically Indicated Cardiac Catheterization |
Primary outcome
Number of Participants With Procedure-Related Adverse Events During Low-SAR MRI-Guided Catheterization
Time frame: During procedure through discharge, up to 4 hours after the procedure
Number of participants with any procedure-related adverse event during MRI-guided cardiac catheterization using passive MRI-compatible catheters and the specified guidewire under defined low-SAR conditions using Common Terminology Criteria for Adverse Events (CTCAE) grading. Events included clinically significant arrhythmia, hemodynamic instability requiring treatment, vascular injury, cardiac perforation/tamponade, device-related heating or burn, or other intervention-related complication. The CTCAE employs a 5-point scale to standardize the grading of adverse events from mild to fatal: * Grade 1 (Mild): Asymptomatic or mild symptoms; no intervention required. * Grade 2 (Moderate): Local/noninvasive intervention needed; limits instrumental ADL. * Grade 3 (Severe): Severe/medically significant; hospitalization or prolongation; limits self-care ADL. * Grade 4 (Life-threatening): Urgent intervention required. * Grade 5 (Fatal): Death related to the adverse event
1 secondary outcome
Number of Participants Who Completed the MRI-guided Portion of Cardiac Catheterization Without Life-threatening Hemodynamic Instability
Time frame: From start of MRI-guided catheterization through completion of the procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29925397Campbell-Washburn AE, Rogers T, Stine AM, Khan JM, Ramasawmy R, Schenke WH, McGuirt DR, Mazal JR, Grant LP, Grant EK, Herzka DA, Lederman RJ. Right heart catheterization using metallic guidewires and low SAR cardiovascular magnetic resonance fluoroscopy at 1.5 Tesla: first in human experience. J Cardiovasc Magn Reson. 2018 Jun 21;20(1):41. doi: 10.1186/s12968-018-0458-7.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No. The authors are willing to share de-identified subject data upon reasonable request
Related trials for Pulmonary Artery Hypertension
RecruitingObservational study
Asthma and Primary Arterial Hypertension: an Inflammatory Link?
Asthma Bronchial
RecruitingPhase 2
Spironolactone for Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension
RecruitingPhase 1/2
A Study of HS235 for Treatment of Pulmonary Arterial Hypertension (PAH) in Adults
Pulmonary Arterial Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
Recruiting
Vasopressor Agents in Pulmonary Hypertension Crisis
Pulmonary Arterial Hypertension (PAH), Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert J Lederman, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI Heart guidewire catheterization in people with Pulmonary Artery Hypertension and Congenital Heart Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Procedure-Related Adverse Events During Low-SAR MRI-Guided Catheterization (time frame: During procedure through discharge, up to 4 hours after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03152773, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.