Mitral Valve Regurgitation of Any Grade Clinical Trial
Official title:
Mitral Valve Regurgitation Quantification From 3D Color Doppler Ultrasound - Standard of Care Data Collection
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.
| Status | Completed |
| Enrollment | 120 |
| Est. completion date | December 31, 2019 |
| Est. primary completion date | July 31, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 85 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Saint Luc University Hospital | Brussels |
| Lead Sponsor | Collaborator |
|---|---|
| Philips Electronics Nederland B.V. acting through Philips CTO organization |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Central diastolic and systolic blood pressures | images and measurements | Day 1 |