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Clinical Trials/NCT02980614
NCT02980614
Unknown
Not Applicable

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

Centre Hospitalier Universitaire, Amiens1 site in 1 country30 target enrollmentMarch 27, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Magnetic Resonance Imaging
Sponsor
Centre Hospitalier Universitaire, Amiens
Enrollment
30
Locations
1
Primary Endpoint
Regurgitant fraction comparison
Last Updated
7 years ago

Overview

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 ? ).

Registry
clinicaltrials.gov
Start Date
March 27, 2017
End Date
December 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Pulmonary arteries flows(Day 0)
  • Right ventricular volume(Day 0)

Study Sites (1)

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