Clinical trial NCT02739087: Radiation-Free Heart Catheterization Using MRI
Official title: Radiation-Free Heart Catheterization Using MRI
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Aortic Coarctation
Cardiomyopathy
Atrial Septal Defect
Aortic Stenosis
Post Heart Transplant Catheter Procedure
Patent Ductus Arteriosus
Keywords: radiation free cardiac catheterization
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
First posted: 2016-04-14
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Test the feasibility of navigating catheters into right heart structures using real-time MRI
timeFrame: At the end of each catheterization procedure through study completion,up to 5 years.
Secondary outcomes:
measure: Number of participants whose MRI cardiac catheterization procedure was prematurely terminated
timeFrame: At the end of each catheterization procedure through study completion,up to 5 years
measure: Measurement of radiation exposure
timeFrame: End of study, 5 years.
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Health System
state: District of Columbia
Study officials:
affiliation: Children's National Research Institute
name: Joshua Kanter, MD
role: PRINCIPAL_INVESTIGATOR
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