Real-time MRI Right Heart Catheterization Using Passive Catheters
Condition: Caridovascular Disease; Congenital Heart Disease; Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Heart Diseases; Heart Defects, Congenital
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Background:

      - Currently, heart catheterization procedures are guided by X-rays. Researchers are
      developing new techniques to perform heart catheterization without the use of X-rays by
      investigating possible uses of magnetic resonance imaging (MRI) scans. To study these uses,
      researchers are interested in performing a part of the standard X-ray catheterization
      procedure using MRI on individuals who are scheduled to have heart catheterization.

      Objectives:

      - To examine the safety and feasibility of right-heart catheterization using MRI-guided
      catheters.

      Eligibility:

      - Individuals at least 21 years of age who are undergoing a medically necessary heart
      catheterization procedure.

      Design:

        -  The research MRI procedure will be performed either before or after standard X-ray
           guided heart catheterization.

        -  Participants will be transferred from an X-ray table onto an MRI table and advanced into
           the scanner. Under MRI guidance, a MRI-compatible catheter will be used to measure blood
           pressure and blood oxygen levels in the heart, and MRI scanning will be performed for
           approximately 30 minutes.
    

Detailed description: 
      Heart catheterization is a minimally invasive procedure to measure pressure and inject dye
      into specific heart cavities. Heart catheterization usually uses X-ray guidance, which
      involves radiation exposure and which fails to visualize soft tissue.

      We have developed real-time magnetic resonance imaging (MRI) to guide heart catheterization
      with tissue visualization but without X-ray radiation. In the first phase of this protocol we
      showed that comprehensive right-sided heart catheterization is feasible in adult patients,
      using commercially available MRI-compatible ( passive ) catheters.

      In the second phase of the protocol, we began performing systematic right-sided heart
      catheterization without X-ray whenever possible. We will assess the hearts response to
      hemodynamic provocation during MRI catheterization tailored to the patient s problem. We will
      use this protocol to further refine the technique

      If successful, this will enable future testing of devices for adult and pediatric MRI-guided
      catheterization, such as special active wire guides, which may lead to new non-surgical
      treatments of cardiovascular disease.
    

Intervention name(s): Cardiac Real-time MRI RHC (Right Heart Catheterization)
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: MRI Catheterization; Right Heart Catheterization; Pulmonary Artery Catheterization; MRI Safety; Jugular Vein Catheterization; Heart Catheterization; Heart Disease; Cardiovascular Disease