Status:
COMPLETED
Mitral Valve Regurgitation Quantification From 3D Color Doppler Ultrasound - Standard of Care Data Collection
Lead Sponsor:
Philips Electronics Nederland B.V. acting through Philips CTO organization
Conditions:
Mitral Valve Regurgitation of Any Grade
Eligibility:
All Genders
18-85 years
Phase:
NA
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 pro...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03286088
Start Date
August 22 2017
End Date
December 31 2019
Last Update
October 27 2021
Active Locations (1)
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1
Saint Luc University Hospital
Brussels, Belgium, 1200