4D Velocity Mapping of the Heart in rTOF Patients

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02980614

Acronym

CARDIOFLUX

Enrollment

Registered

2016-12-02

Start date

2017-03-27

Completion date

2020-03-03

Last updated

2026-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Magnetic Resonance Imaging, Tetralogy of Fallot

Keywords

phase-contrast MRI, blood flow, velocity mapping, Quantitative MRI, Cardiac imaging, Tetralogy of Fallot

Brief summary

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

Detailed description

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 ? ).

Interventions

DEVICE4D flow imaging

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Regurgitant fraction comparison	Day 0	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.

Secondary

Measure	Time frame	Description
Right ventricular volume	Day 0	The secondary objective is to compare the right ventricular volumes measured using the 4D prototype and the standard steady-state free precession sequences.
Pulmonary arteries flows	Day 0	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 ? ).

Countries

France

Contacts

PRINCIPAL_INVESTIGATORCedric Renard, MD

CHU Amiens

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 26, 2026