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Enrolling by invitationNCT07742046Updated Aug 3, 2026

Feasibility of Non-invasive Hemodynamic Assessment by 5D Flow in Congenital Heart Disease

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

Phase
Not applicable
Study type
Interventional
Enrollment
130
Allocation
Not applicable
Ages
16 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Pulmonary Hypertension
  • Right Ventricular Outflow Tract Dysfunction
  • Fontan Circulation

Keywords

  • 5D flow
  • cardiac magnetic resonance imaging
  • congenital heart disease
  • iCMR
03

In context

Hypertension, Pulmonary

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 →

Lead sponsor

This is the only study on the registry with Tobias Rutz as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Referral for work-up of known or suspected pulmonary hypertension (PH), RVOT pathology, or Fontan-type repair with a clinical indication for RL-HC.
  • Ability to provide informed consent or have consent provided by a legal representative (and assent for minors aged 16-18).
  • Male or female participants of all ethnicities and sociodemographic backgrounds

Exclusion criteria

Exclusion Criteria:

  • Participants unable to comply with study procedures due to language barriers, cognitive or psychological limitations, or lack of legal consent.
  • Patients with contraindications to RL-HC or CMR.
  • Patients not having a clinical indication to RL-HC.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
130 participants (estimated)

Study arms

  • Experimental
    Patients undergoing iCMR

    Patients undergoing iCMR

    Diagnostic Test: Right-left heart catheterization in magnetic resonance imaging (MRI)

Interventions

  • Diagnostic testRight-left heart catheterization in magnetic resonance imaging (MRI)

    Right-left heart catheterization in MRI

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

07

Study locations

1 site
  • Lausanne University Hospital
    Lausanne, 1011, Switzerland
08

References and documents

Individual participant data

Plan to share: Yes — Data can be shared upon reasonable request

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07742046
Lead sponsor
Tobias Rutz
Responsible party
Tobias Rutz (Principal Investigator, University of Lausanne Hospitals) — Sponsor-investigator
First posted
Aug 3, 2026
Start date
Jul 6, 2026
Primary completion
May 31, 2029 (estimated)
Completion
May 31, 2029 (estimated)
Last update
Aug 3, 2026

Study contacts

Tobias Rutz, MD
principal investigator · University of Lausanne Hospitals

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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