4D Velocity Mapping of the Heart in rTOF Patients (CARDIOFLUX)
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|ClinicalTrials.gov Identifier: NCT02980614|
Recruitment Status : Unknown
Verified August 2018 by Centre Hospitalier Universitaire, Amiens.
Recruitment status was: Recruiting
First Posted : December 2, 2016
Last Update Posted : August 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Magnetic Resonance Imaging Tetralogy of Fallot||Device: 4D flow imaging||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Cardiac 4D MR Velocity Mapping in Repaired Tetralogy of Fallot Patients: Evaluation of Pulmonary Regurgitant Fraction and Ventricular Volume|
|Actual Study Start Date :||March 27, 2017|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Participants to 4D flow imaging
In addition to the standard clinical MR protocol, 2 added sequences:
4D MR sequence in cine mode 4D velocity mapping sequence
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
- 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.
- 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.
- 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 ? ).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02980614
|Contact: Cedric Renard, MD||+33 3 22 08 75 email@example.com|
|Amiens, France, 80054|
|Contact: Cedric Renard, MD +33 3 22 08 75 37 firstname.lastname@example.org|
|Sub-Investigator: Amel Mathiron, MD|
|Principal Investigator:||Cedric Renard, MD||CHU Amiens|