Heart Catheterization Using Magnetic Resonance Imaging (MRI) Fluoroscopy and Passive Guidewires

NCT03152773 | Terminated Results DMC FDA Device

• 2 other identifiers: 17009517-H-0095
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pulmonary Artery Hypertension; Congenital Heart Disease; Structural Heart Disease

Keywords

MRI Catheterization; Real-time MRI

Outcome Measures

Primary Outcomes (1)

• 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

  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

  From start of MRI-guided catheterization through completion of the procedure

Study Arms (1)

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.

Diagnostic Test: MRI Heart guidewire catheterization

Interventions

MRI Heart guidewire catheterization DIAGNOSTIC_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.

Participants Undergoing Clinically Indicated Cardiac Catheterization

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• 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.

  PMID: 29925397 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Familial Primary Pulmonary Hypertension; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Dr. Robert Lederman, Principal Investigator
• Organization: National Heart, Lung, and Blood Institute (NHLBI)

Robert.Lederman@nih.gov

301.402.6769

Study Officials

• Robert J Lederman, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2017
• First Posted: May 15, 2017
• Study Start: August 2, 2017
• Primary Completion: December 14, 2021
• Study Completion: December 14, 2021
• Last Updated: July 15, 2026
• Results First Posted: July 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)