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

Sponsor
Tobias Rutz
Study ID
NCT07742046
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Aug 3, 2026
Start date
Jul 6, 2026
Status verified
Jul 2026
Primary completion
May 31, 2029
Completion
May 31, 2029

Study Design

Enrollment
130 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Patients undergoing iCMR
    Patients undergoing iCMR

Primary Outcome Measure

Vorticity (s-1) [ Time Frame: Periprocedural ]

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