An interventional study of Right-left heart catheterization in magnetic resonance imaging (MRI) in Pulmonary Hypertension, Right Ventricular Outflow Tract Dysfunction and Fontan Circulation, sponsored by Tobias Rutz. Enrolling by invitation at 1 site in Switzerland. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by Tobias Rutz · Not applicable, Interventional, and Diagnostic
This study evaluates whether new flow parameters of the cardiac magnetic resonance imaging (MRI) allow evaluation of parameters for which usually invasive rigth-left heart catheterization are necessary. Patients who require a right-left heart catheterization will undergo the same day a heart catheterization in the MRI. Parameters obtained by MRI will be compared to the gold-standard, the right-left heart catheterization.
Because of progress in early diagnosis, surgery, and medical treatment, almost all patients with congenital heart disease (CHD) survive nowadays into adulthood. However, most patients cannot be considered as cured as they are at high risk for complications like heart failure, valvopathies and pulmonary arterial hypertension (PAH). Treatment and diagnosis of these complications require often repetitive right-left heart catheterizations (RL-HC) for hemodynamic evaluations which are associated with a procedural risk, particularly in young patients in addition to a repeated radiation exposure. Advanced flow parameters obtained by the recently introduced Cardiac Magnetic Resonance (CMR) 4D flow technique promise non-invasive evaluation of hemodynamic parameters like pressure gradients and vascular resistance opening the door to partially replace RL-HC. However, 4D flow is limited by the need for ECG detection and cardiac movement during respiration. A new fully self-gated 5D CMR framework to cardiac and respiratory motion-resolved 3D flow imaging-5D flow aims to overcome these limitations. In addition, respiratory resolved flow determination is possible. As a result, 5D flow is a potentially powerful tool for the non-invasive assessment of hemodynamics like filling pressures and vascular resistance.
In the proposed study, patients will undergo a CMR-guided RL-HC in addition to a clinically indicated RL-HC.
As CMR is the gold standard for non-invasive flow determination, the combination of CMR-derived flow and RL-HC-derived pressures allows a precise evaluation of vascular resistance as it overcomes the limitations of the classic invasive methods for determination of cardiac output like the Fick or thermodilution techniques and the radiation exposure. This is particularly interesting in CHD patients in whom e.g. pulmonary resistance can differ in both lungs. For this reason, CMR guided heart catheterization (iCMR) is therefore increasingly incorporated in the routine use in different centers.
This study evaluates the feasibility of the determination of the relationship between noninvasive advanced 5D flow parameters and invasive catheter-derived vascular and ventricular hemodynamic parameters in PH/PAH and CHD patients. This will help to improve diagnosis and knowledge of the pathophysiological mechanisms in these complex patients.
All patients will undergo a clinical indicated standard RL-HC. In Fontan patients, a liver biopsy will be performed which is part of the routine follow-up for these patients. The participants are transferred to the interventional CMR suite. A RL-HC will be performed under CMR control. Invasive pressure measurements will be performed at predefined positions. After the RL-HC, the 5D flow will be obtained as well as a standard cardiac magnetic resonance imaging for determination of ventricular function and standard 2D and 4D flow.
1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.
This study's planned enrollment of 130 is above the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.
Browse Hypertension, Pulmonary studies →This is the only study on the registry with Tobias Rutz as lead sponsor.
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Exclusion Criteria:
Patients undergoing iCMR
Diagnostic Test: Right-left heart catheterization in magnetic resonance imaging (MRI)
Right-left heart catheterization in MRI
Vorticity (s-1)
Vorticity is defined as the curl of the velocity quantifying the rotation around an axis of individual fluid particles. The parameters will be determined by the cardiac magnetic resonance 5D flow technique.
Time frame: Periprocedural
Helicity (m⁴/s²)
Helicity quantifies the helical flow or flow with a corkscrew-like motion in one direction and is proportional to the velocity and the vorticity, reflecting stability of laminar flow The parameter will be determined by the cardiac magnetic resonance 5D flow technique.
Time frame: Periprocedural
Pressure maps (mmHg)
With the the help of the cardiac magnetic resonance 5D flow technique a pressure map over a valvular/vascular stenosis will be determined
Time frame: Periprocedural
Kinetic energy (KE) (J) and its loss (EL, J/m3)
Kinetic energy represents the amount of energy in the blood flow due to its motion. This parameters will be determined by the cardiac magnetic resonance imaging 5D flow technique.
Time frame: Periprocedural
Plan to share: Yes — Data can be shared upon reasonable request
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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