Trial Outcomes & Findings for Heart Catheterization Using Magnetic Resonance Imaging (MRI) Fluoroscopy and Passive Guidewires (NCT NCT03152773)
NCT ID: NCT03152773
Last Updated: 2026-07-15
Results Overview
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
TERMINATED
NA
22 participants
During procedure through discharge, up to 4 hours after the procedure
2026-07-15
Participant Flow
Participant milestones
| Measure |
Participants Undergoing Clinically Indicated Cardiac Catheterization
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.
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|---|---|
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Overall Study
STARTED
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22
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Overall Study
COMPLETED
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16
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Overall Study
NOT COMPLETED
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6
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Reasons for withdrawal
| Measure |
Participants Undergoing Clinically Indicated Cardiac Catheterization
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.
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|---|---|
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Overall Study
Procedural Issue Requiring Bailout
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6
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Baseline Characteristics
Heart Catheterization Using Magnetic Resonance Imaging (MRI) Fluoroscopy and Passive Guidewires
Baseline characteristics by cohort
| Measure |
Participants Undergoing Clinically Indicated Cardiac Catheterization
n=22 Participants
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.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=20 Participants
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Age, Categorical
Between 18 and 65 years
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15 Participants
n=20 Participants
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Age, Categorical
>=65 years
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7 Participants
n=20 Participants
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Sex: Female, Male
Female
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14 Participants
n=20 Participants
|
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Sex: Female, Male
Male
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8 Participants
n=20 Participants
|
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Ethnicity (NIH/OMB)
Hispanic or Latino
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3 Participants
n=20 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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19 Participants
n=20 Participants
|
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=20 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=20 Participants
|
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Race (NIH/OMB)
Asian
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2 Participants
n=20 Participants
|
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
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10 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
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8 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
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2 Participants
n=20 Participants
|
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Region of Enrollment
United States
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22 participants
n=20 Participants
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PRIMARY outcome
Timeframe: During procedure through discharge, up to 4 hours after the procedurePopulation: 6 participants did not complete the MRI-guided catheterization due to procedural limitations
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
Outcome measures
| Measure |
Participants Undergoing Clinically Indicated Cardiac Catheterization
n=16 Participants
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.
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|---|---|
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Number of Participants With Procedure-Related Adverse Events During Low-SAR MRI-Guided Catheterization
Grade 1
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1 Participants
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Number of Participants With Procedure-Related Adverse Events During Low-SAR MRI-Guided Catheterization
Grade 2
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1 Participants
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Number of Participants With Procedure-Related Adverse Events During Low-SAR MRI-Guided Catheterization
Grade 3
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0 Participants
|
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Number of Participants With Procedure-Related Adverse Events During Low-SAR MRI-Guided Catheterization
Grade 4
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0 Participants
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Number of Participants With Procedure-Related Adverse Events During Low-SAR MRI-Guided Catheterization
Grade 5
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0 Participants
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Number of Participants With Procedure-Related Adverse Events During Low-SAR MRI-Guided Catheterization
No Procedure-Related Adverse Event
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14 Participants
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SECONDARY outcome
Timeframe: From start of MRI-guided catheterization through completion of the procedurePopulation: 6 participants did not complete the MRI-guided catheterization due to procedural limitations
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
Outcome measures
| Measure |
Participants Undergoing Clinically Indicated Cardiac Catheterization
n=16 Participants
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.
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|---|---|
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Number of Participants Who Completed the MRI-guided Portion of Cardiac Catheterization Without Life-threatening Hemodynamic Instability
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16 Participants
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Adverse Events
Participants Undergoing Clinically Indicated Cardiac Catheterization
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Participants Undergoing Clinically Indicated Cardiac Catheterization
n=22 participants at risk
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.
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|---|---|
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General disorders
Mild Groin Pain
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4.5%
1/22 • Number of events 1 • During procedure through discharge, up to 4 hours after the procedure
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Musculoskeletal and connective tissue disorders
Back Pain
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4.5%
1/22 • Number of events 1 • During procedure through discharge, up to 4 hours after the procedure
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Additional Information
Dr. Robert Lederman, Principal Investigator
National Heart, Lung, and Blood Institute (NHLBI)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place