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Completed

NCT Number: NCT02980614

4D Velocity Mapping of the Heart in rTOF Patients

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

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Key information

Conditions

Magnetic Resonance Imaging Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Tetralogy of Fallot

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens

Amiens, 80054, France

About this study

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 ? ).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

4D flow imaging

Device

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

Primary outcomes

  1. Regurgitant fraction comparison

    Time frame: 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 outcomes

  1. Right ventricular volume

    Time frame: 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.

  2. Pulmonary arteries flows

    Time frame: 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 ? ).

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

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

Acronym: CARDIOFLUX

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 2, 2016
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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