Mitral Valve Regurgitation of Any Grade
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTTransEsophageal Echocardiography and TransEsophageal Echocardiography
imaging as standard practice
DIAGNOSTIC_TESTCardiac Magnetics Resonance
imaging as standard practice
DIAGNOSTIC_TESTMitraClip
imaging as standard practice
Sponsors
Philips Electronics Nederland B.V. acting through Philips CTO organization
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Central diastolic and systolic blood pressures | Day 1 | images and measurements |
Countries
Belgium
Outcome results
None listed