4D Velocity Mapping of the Heart in rTOF Patients

Not Applicable

• Conditions: Magnetic Resonance Imaging; Tetralogy of Fallot
• Interventions: Device: 4D flow imaging

• Registration Number: NCT02980614
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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 ? ).

Study Timeline

• Study First Submitted: 2016-11-10
• Study First Submitted QC: 2016-11-30
• Study First Posted: 2016-12-02
• Study Start: 2017-03-27
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-03
• Last Update Posted: 2018-08-06
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants to 4D flow imaging	4D flow imaging	In addition to the standard clinical MR protocol, 2 added sequences: 4D MR sequence in cine mode 4D velocity mapping sequence

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 ? ).
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.

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France