Radiation-Free Heart Catheterization Using MRI

Not Applicable

Active, not recruiting

• Conditions: Atrial Septal Defect; Cardiomyopathy; Patent Ductus Arteriosus; Aortic Coarctation; Aortic Stenosis; Post Heart Transplant Catheter Procedure
• Interventions: Procedure: MRI guided cardiac catheterization; Device: Magnetic resonance imaging

• Registration Number: NCT02739087
• Lead Sponsor: Joshua Kanter

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2016-02-17
• Study First Submitted QC: 2016-04-13
• Study First Posted: 2016-04-14
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-06
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MRI guided cardiac catheterization	Magnetic resonance imaging	Magnetic resonance imaging will be used to guide cardiac catheterization procedures.
MRI guided cardiac catheterization	MRI guided cardiac catheterization	Magnetic resonance imaging will be used to guide cardiac catheterization procedures.

Primary Outcome Measures

Name	Time	Method
Test the feasibility of navigating catheters into right heart structures using real-time MRI	At the end of each catheterization procedure through study completion,up to 5 years.	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.

Secondary Outcome Measures

Name	Time	Method
Measurement of radiation exposure	End of study, 5 years.	Comparison of radiation exposure in this cohort of subjects to historical controls undergoing matched invasive cardiology procedure at CNMC.
Number of participants whose MRI cardiac catheterization procedure was prematurely terminated	At the end of each catheterization procedure through study completion,up to 5 years	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

Trial Locations

Locations (1)

Children's National Health System; 🇺🇸 Washington, District of Columbia, United States