Mitral Valve Regurgitation Quantification From 3D Color Doppler Ultrasound - Standard of Care Data Collection

Study Overview
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Brief Summary
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The study primarily aims to collect standard of care clinical data in a wide spectrum of simple to complex mitral valve regurgitation (MVR) cases to validate a post-processing stand-alone software prototype (QFlow), developed by Philips Research Paris (Medisys). Investigator does not intervene in the care of the patient, but simply collects standard of care images and measurements that are needed for the validation of the investigational software.

Official Title
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Mitral Valve Regurgitation Quantification From 3D Color Doppler Ultrasound - Standard of Care Data Collection

Conditions
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Mitral Valve Regurgitation of Any Grade

Intervention / Treatment
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* Diagnostic Test: TransEsophageal Echocardiography and TransEsophageal Echocardiography
* Diagnostic Test: Cardiac Magnetics Resonance
* Diagnostic Test: MitraClip


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: both genders age between 18 and 85 years old (adult, senior) sinus rhythm hHemodynamic stable mitral valve regurgitation (MVR) of any grade i.e., from mild to severe as determined by assessment of a qualifying TransThoracic Echocardiography (TTE) exam at Saint-Luc University Hospital scheduled for TransEsophageal Echocardiography (TEE) at Saint-Luc University Hospital, as part of the subject's routine standard of care subjects has functional capacity to give written informed consent Exclusion Criteria: pregnancy subject lacks functional capacity to give written informed consent belongs to a vulnerable population per investigator's judgment or subject has any kind of disorder that compromises his/her ability to give written informed consent and/or to comply with study procedures Among the120 subjects, there will be three (3) sub-groups as follows: a first sub-group (A) of 50 subjects with all inclusion criteria and none of the exclusion criteria a second sub-group (B) of 50 subjects with additional inclusion criterion: scheduled for cardiac Magnetic Resonance (cMR), as part of the subject's routine standard of care a third sub-group (C) of 20 subjects with additional inclusion criterion: scheduled for MitraClip transcatheter mitral valve repair (MitraClip) procedure as part of the subject's routine standard of care

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group A<br>TransEsophageal Echocardiography + TransThoracic Echocardiography | Diagnostic Test: TransEsophageal Echocardiography and TransEsophageal Echocardiography<br>* imaging as standard practice<br>|
| Other: Group B<br>TransEsophageal Echocardiography + TransThoracic Echocardiography + cardiac Magnetic Resonance | Diagnostic Test: TransEsophageal Echocardiography and TransEsophageal Echocardiography<br>* imaging as standard practice<br>Diagnostic Test: Cardiac Magnetics Resonance<br>* imaging as standard practice<br>|
| Other: Group C<br>TransEsophageal Echocardiography + TransThoracic Echocardiography + MitraClip | Diagnostic Test: TransEsophageal Echocardiography and TransEsophageal Echocardiography<br>* imaging as standard practice<br>Diagnostic Test: MitraClip<br>* imaging as standard practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central diastolic and systolic blood pressures | images and measurements | Day 1 |