Radiation-Free Heart Catheterization Using MRI

Aortic Stenosis Clinical Trial

Official title:

Radiation-Free Heart Catheterization Using MRI

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02739087
• Other study ID #: 3860
• Secondary ID: Internal Bridge
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 2015
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Children's National Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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 Exclusion criteria for Gadolinium (contrast agent)

1. Renal disease with estimated glomerular filtration rate < 30 ml/min/1.73 m2 body surface area

Related Conditions & MeSH terms

• Aortic Coarctation
• Aortic Stenosis
• Aortic Valve Stenosis
• Atrial Septal Defect
• Cardiomyopathies
• Cardiomyopathy
• Ductus Arteriosus, Patent
• Heart Septal Defects, Atrial
• Patent Ductus Arteriosus
• Post Heart Transplant Catheter Procedure

Intervention

Procedure:
• 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.

Device:
• Magnetic resonance imaging

Locations

Country	Name	City	State
United States	Children's National Health System	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Joshua Kanter

Country where clinical trial is conducted

United States, 

References & Publications (63)

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* Note: There are 63 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test the feasibility of navigating catheters into right heart structures using real-time MRI	Heart catheterization usually uses X-ray guidance. Using commercially available MRI-compatible catheters, the right heart catheterization procedure will be done using real-time magnetic resonance imaging (MRI). MRI guidance does not use X-ray radiation.	At the end of each catheterization procedure through study completion,up to 5 years.
Secondary	Number of participants whose MRI cardiac catheterization procedure was prematurely terminated	Premature termination will occur under the following circumstances: Hemodynamic or other clinical instability; Technical failure of catheter procedure such as being unable to navigate the catheters to the heart chamber; Equipment malfunction; Any other circumstance that in the opinion of the Principal Investigator poses hazard to the research subject	At the end of each catheterization procedure through study completion,up to 5 years
Secondary	Measurement of radiation exposure	Comparison of radiation exposure in this cohort of subjects to historical controls undergoing matched invasive cardiology procedure at CNMC.	End of study, 5 years.