4D Velocity Mapping of the Heart in rTOF Patients (CARDIOFLUX)

Centre Hospitalier Universitaire, Amiens

Status: Unknown

Conditions: Tetralogy of Fallot; Magnetic Resonance Imaging

Treatments: Device: 4D flow imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT02980614

PI2016_843_0026

Details and patient eligibility

About

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

Full 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 ? ).

Enrollment: 30 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Participants to 4D flow imaging

Experimental group

Description:

In addition to the standard clinical MR protocol, 2 added sequences: 4D MR sequence in cine mode 4D velocity mapping sequence

Treatment:

Device: 4D flow imaging