4D Velocity Mapping of the Heart in rTOF Patients

Study Overview
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Brief Summary
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MRI with 4D flow permits to assess the hemodynamic parameters in a parent vessel and its branches inside the same sequence.

Detailed Description
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MRI with 4D flow permits to assess the hemodynamic parameters in a parent vessel and its branches inside the same sequence. The objective of the project is to compare the regurgitant fraction in the pulmonary artery (PA) measured using 4D MR-flow and standard 2D MR-flow in repaired Tetralogy of Fallot (rTOF) patients. The consistency of the 4D flow quantization will be assessed assuming mass conservation in the pulmonary artery tree (PA flow =LeftPA flow +RightPA flow ? ).

Official Title
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Cardiac 4D MR Velocity Mapping in Repaired Tetralogy of Fallot Patients: Evaluation of Pulmonary Regurgitant Fraction and Ventricular Volume

Conditions
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Magnetic Resonance Imaging, Tetralogy of Fallot

Intervention / Treatment
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* Device: 4D flow imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Tetralogy of Fallot patients referred for clinical MRI examination ≥ 15 years Exclusion Criteria: Anyone with a classic contraindication to MRI Severe obesity Gadolinium chelate allergy < 15 years counter-indication to MRI examination vulnerable person

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants to 4D flow imaging<br>In addition to the standard clinical MR protocol, 2 added sequences: 4D MR sequence in cine mode 4D velocity mapping sequence | Device: 4D flow imaging<br>* To compare the quantification of pulmonary valve leakage by standard 2D flow MRI and 4D flow MRI by measuring the regurgitation fraction (ratio of retrograde blood flow to anterograde flow) in the pulmonary artery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regurgitant fraction comparison | The primary objective of the project is to compare the regurgitant fraction in the pulmonary artery (PA) measured with 4D MR-flow and standard 2D MR-flow. | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Right ventricular volume | The secondary objective is to compare the right ventricular volumes measured using the 4D prototype and the standard steady-state free precession sequences. | Day 0 | 
| Pulmonary arteries flows | The consistency of the 4D flow quantization will be assessed assuming mass conservation in the pulmonary artery (PA) tree (PA flow =LeftPA flow +RightPA flow ? ). | Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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phase-contrast MRI, blood flow, velocity mapping, Quantitative MRI, Cardiac imaging, Tetralogy of Fallot