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Passive Guidewire
MRI-Guided Catheterization for Heart Disease
N/A
Recruiting
Led By Robert J Lederman, M.D.
Research Sponsored by National Heart, Lung, and Blood Institute (NHLBI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Undergoing medically necessary diagnostic or interventional right cardiovascular catheterization, alone or in combination with a left cardiovascular catheterization
Age greater than or equal to 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 hours
Awards & highlights
Study Summary
This trial is testing if special MRI settings make it safe to use a guidewire during MRI fluoroscopy. Researchers will compare the safety of the special MRI settings with the safety of standard MRI settings.
Who is the study for?
This trial is for adults over 18 who need a heart catheterization, which is a procedure to check heart function. Participants must not be pregnant or nursing, have severe heart valve issues, unstable heart conditions like ongoing attacks or failure, and can't have certain metal implants or allergies to MRI contrast agents.Check my eligibility
What is being tested?
The study tests if using special guidewires during an MRI-guided heart catheterization is safe with low energy settings that prevent the wires from heating up. This could make the procedure quicker and reduce time in the MRI machine.See study design
What are the potential side effects?
Potential side effects may include discomfort from lying still inside the MRI scanner for up to two hours, risks associated with sedation and catheter insertion such as bleeding or infection at the site of entry, and possible allergic reactions to materials used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for a heart catheterization procedure.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The principal objective of this protocol is to test the safety and feasibility of MRI fluoroscopy catheter navigation using 0.035 guidewires during left and right heart catheterization guided by low-SAR MRI pulse sequences
Secondary outcome measures
Additional objectives are to test and enhanced MRI as an adjunct to routine hemodynamic cardiac catheterization
Trial Design
1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment1 Intervention
Open label
Find a Location
Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)Lead Sponsor
3,838 Previous Clinical Trials
47,851,554 Total Patients Enrolled
2 Trials studying Structural Heart Disease
1,150 Patients Enrolled for Structural Heart Disease
Robert J Lederman, M.D.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)
12 Previous Clinical Trials
745 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a severe narrowing of my heart's aortic valve.I am not pregnant or nursing.You cannot have a magnetic resonance imaging (MRI) scan.I do not have unstable heart conditions like ongoing heart attacks or severe heart failure.I have a foreign object, like metal, in my eye.My kidney function is significantly reduced.You are using a neural stimulator, like a TENS unit.I am scheduled for a heart catheterization procedure.I am 18 years old or older.I do not want to receive ferumoxytol treatment.You have metal pieces or bullets in your body.You have any type of ear implant.You are allergic to ferumoxytol or mannitol.You have a metal clip in your brain to treat an aneurysm.
Research Study Groups:
This trial has the following groups:- Group 1: 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the patient quota for this clinical trial?
"Affirmative. According to information hosted on clinicaltrials.gov, this medical experiment is currently recruiting patients and was first posted on August 2nd 2017 before being updated November 19th 2022. It seeks 100 participants from a single site for its research endeavors."
Answered by AI
Is the eligibility criteria for this experiment restricted to individuals aged over 20?
"This clinical trial has set the minimal age for entry at 18 years old, with the upper limit being 99."
Answered by AI
Can participants still join this investigation?
"According to clinicaltrials.gov, this experiment has been open for recruitment since August 2nd 2017 and was most recently updated on November 19th 2022."
Answered by AI
Am I eligible to partake in this clinical trial?
"The requirements to participate in this study are: having a congenital heart defect, being between 18 and 99 years of age. Up to 100 individuals will be selected for the trial."
Answered by AI
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