Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
NA
Total Enrollment
50 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-03-31
Study Completion Date
2024-12-31
Brief Summary
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Currently catheters used in heart catheterization procedures are guided throughout the heart chambers and blood vessels by pictures taken by x-rays. This technology exposes patients to radiation. With this study protocol the investigators will use MRI technology to take real-time pictures to navigate catheters throughout heart chambers. MRI uses electromagnetic energy; therefore, it does not expose participants to radiation energy.
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Detailed Description
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Participants undergo general anesthesia, and vascular access is obtained in the x-ray catheterization lab. Next the participant is transferred into the MRI scanner where a focused MRI examination is performed. Catheters are then guided into the heart chambers using real-time MRI guidance to perform conventional cardiac catheterization steps. If time allows, additional research MRI is performed before the participant is returned to the x-ray catheterization lab. If any MRI guided catheterization steps are unsuccessful, the clinically indicated step is performed after the participant returns to the x-ray catheterization lab using conventional x-ray guided pictures.
Conditions
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Aortic Coarctation
Cardiomyopathy
Atrial Septal Defect
Aortic Stenosis
Post Heart Transplant Catheter Procedure
Patent Ductus Arteriosus
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
DIAGNOSTIC
Blinding Strategy
NONE
Study Groups
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MRI guided cardiac catheterization
Magnetic resonance imaging will be used to guide cardiac catheterization procedures.
Group Type
EXPERIMENTAL
MRI guided cardiac catheterization
Intervention Type
PROCEDURE
Magnetic resonance imaging will be used to guide cardiac catheterization procedures whenever possible to avoid or minimize x-ray radiation exposure.
Magnetic resonance imaging
Intervention Type
DEVICE
Interventions
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MRI guided cardiac catheterization
Magnetic resonance imaging will be used to guide cardiac catheterization procedures whenever possible to avoid or minimize x-ray radiation exposure.
Intervention Type
PROCEDURE
Magnetic resonance imaging
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
* Undergoing a medically necessary cardiovascular catheterization
Exclusion Criteria
* Cardiovascular instability including hemodynamic instability (such as requiring significant vasoactive infusion support) or mechanical hemodynamic support.
* Women who are pregnant
* Women who are nursing and who do not plan to discard breast milk for 24 hours
* Patients with a contraindication to MRI scanning will be excluded. These contraindications include patients with the following devices:
1. Central nervous system aneurysm clips
2. Implanted neural stimulator
3. Implanted cardiac pacemaker or defibrillator which are not MR safe or MR conditional according to the manufacturer
4. Cochlear implant
5. Ocular foreign body (e.g. metal shavings)
6. Implanted Insulin pump
7. Metal shrapnel or bullet
1\. Renal disease with estimated glomerular filtration rate \< 30 ml/min/1.73 m2 body surface area
* Women who are pregnant
* Women who are nursing and who do not plan to discard breast milk for 24 hours
* Patients with a contraindication to MRI scanning will be excluded. These contraindications include patients with the following devices:
1. Central nervous system aneurysm clips
2. Implanted neural stimulator
3. Implanted cardiac pacemaker or defibrillator which are not MR safe or MR conditional according to the manufacturer
4. Cochlear implant
5. Ocular foreign body (e.g. metal shavings)
6. Implanted Insulin pump
7. Metal shrapnel or bullet
1\. Renal disease with estimated glomerular filtration rate \< 30 ml/min/1.73 m2 body surface area
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Joshua Kanter
OTHER
Sponsor Role
lead
Responsible Party
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Joshua Kanter
MD
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Joshua Kanter, MD
Role: PRINCIPAL_INVESTIGATOR
Children's National Research Institute
Locations
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Children's National Health System
Washington D.C., District of Columbia, United States
Site Status
Countries
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United States
References
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Reference Type
BACKGROUND
Ratnayaka K, Kanter JP, Faranesh AZ, Grant EK, Olivieri LJ, Cross RR, Cronin IF, Hamann KS, Campbell-Washburn AE, O'Brien KJ, Rogers T, Hansen MS, Lederman RJ. Radiation-free CMR diagnostic heart catheterization in children. J Cardiovasc Magn Reson. 2017 Sep 6;19(1):65. doi: 10.1186/s12968-017-0374-2.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Internal Bridge funding
Identifier Type: OTHER
Identifier Source: secondary_id
3860
Identifier Type: -
Identifier Source: org_study_id
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