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Diagnostic Imaging
XFM-Guided Catheterization for Congenital Heart Defects
N/A
Waitlist Available
Led By Joshua Kanter, MD
Research Sponsored by Joshua Kanter
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the end of each catheterization procedure through study completion,up to 8 years.
Awards & highlights
Study Summary
This trial will determine if using x-rays fused with MR images can help guide catheter tools during cardiac procedures.
Who is the study for?
This trial is open to children and adults of any age who need a heart catheterization for diagnostic or treatment purposes. It's not suitable for those with unstable heart conditions, pregnant or nursing women (unless they can discard breast milk for 24 hours), or anyone with certain metal implants that are unsafe in MRI machines.Check my eligibility
What is being tested?
The study is testing the use of XFM, which combines x-ray and MRI imaging, to guide catheters during heart procedures. The goal is to see if this method improves the accuracy and safety of these medical interventions.See study design
What are the potential side effects?
Since XFM guidance is an imaging technique rather than a drug, it doesn't have typical side effects. However, there may be risks associated with exposure to radiation from x-rays and potential issues related to being in an MRI machine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at the end of each catheterization procedure through study completion,up to 8 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the end of each catheterization procedure through study completion,up to 8 years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Radiation exposure measurement
Secondary outcome measures
Contrast volume measurement
Fluoroscopy
Procedure time measurement
Trial Design
1Treatment groups
Experimental Treatment
Group I: XFM guidanceExperimental Treatment1 Intervention
X-ray fused cardiac MRI images used for guidance tool to perform cardiac catheterization procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
XFM guidance
2013
N/A
~30
Find a Location
Who is running the clinical trial?
Joshua KanterLead Sponsor
1 Previous Clinical Trials
50 Total Patients Enrolled
Joshua Kanter, MDPrincipal InvestigatorChildren's National Hospital System
2 Previous Clinical Trials
132 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are not able to have an MRI scan because you have metal implants that are not safe for MRI scanning.People of any age having a necessary heart procedure called cardiovascular catheterization.
Research Study Groups:
This trial has the following groups:- Group 1: XFM guidance
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.
Are there still vacancies in this medical experiment that participants can fill?
"As per the clinicaltrials.gov database, this medical trial is no longer enrolling participants at present time. The research was initially posted on July 23rd 2013 and underwent its last update on March 28th 2022. Nevertheless, there are still 99 other trials actively seeking to add patients to their studies as we speak."
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