NCT07742046

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
34mo left

Started Jul 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Jul 2026May 2029

Study Start

First participant enrolled

July 6, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 7, 2026

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 3, 2026

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2029

Last Updated

August 3, 2026

Status Verified

July 1, 2026

Enrollment Period

2.9 years

First QC Date

July 7, 2026

Last Update Submit

July 28, 2026

Conditions

Pulmonary HypertensionFontan CirculationRight Ventricular Outflow Tract Dysfunction

Keywords

5D flowcardiac magnetic resonance imagingcongenital heart diseaseiCMR

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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

    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.

    Periprocedural

Study Arms (1)

Patients undergoing iCMR

EXPERIMENTAL

Patients undergoing iCMR

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

Interventions

Right-left heart catheterization in magnetic resonance imaging (MRI)DIAGNOSTIC_TEST

Right-left heart catheterization in MRI

Patients undergoing iCMR

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lausanne University Hospital

Lausanne, 1011, Switzerland

Location

MeSH Terms

Conditions

Hypertension, PulmonaryHeart Defects, Congenital

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular DiseasesCardiovascular AbnormalitiesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Tobias Rutz, MD

    University of Lausanne Hospitals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 7, 2026

First Posted

August 3, 2026

Study Start

July 6, 2026

Primary Completion (Estimated)

May 31, 2029

Study Completion (Estimated)

May 31, 2029

Last Updated

August 3, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

Data can be shared upon reasonable request

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
not yet defined
Access Criteria
upon reaonsalbe request

Locations

CH(1)