Radiation-Free Heart Catheterization Using MRI

Joshua Kanter

Status: Active, not recruiting

Conditions: Cardiomyopathy; Post Heart Transplant Catheter Procedure; Atrial Septal Defect; Aortic Coarctation; Aortic Stenosis; Patent Ductus Arteriosus

Treatments: Procedure: MRI guided cardiac catheterization; Device: Magnetic resonance imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT02739087

3860

Internal Bridge funding (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

MRI guided cardiac catheterization

Experimental group

Description:

Magnetic resonance imaging will be used to guide cardiac catheterization procedures.

Treatment:

Procedure: MRI guided cardiac catheterization

Device: Magnetic resonance imaging