4D Velocity Mapping of the Heart in rTOF Patients

Magnetic Resonance Imaging Clinical Trial

— CARDIOFLUX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02980614
• Other study ID #: PI2016_843_0026
• Status: Recruiting
• Phase: N/A
• Start date: March 27, 2017
• Est. completion date: December 2019

Study information

• Verified date: August 2018
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Cedric Renard, MD
• Phone: +33 3 22 08 75 37
• Email: renard.cedric[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 ? ).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Magnetic Resonance Imaging
• Tetralogy of Fallot

Intervention

Device:
• 4D 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

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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