Mitral Valve Regurgitation Quantification From 3D Color Doppler Ultrasound - Standard of Care Data Collection
NCT ID: NCT03286088
Last Updated: 2021-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2017-08-22
2019-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Group A
TransEsophageal Echocardiography + TransThoracic Echocardiography
TransEsophageal Echocardiography and TransEsophageal Echocardiography
imaging as standard practice
Group B
TransEsophageal Echocardiography + TransThoracic Echocardiography + cardiac Magnetic Resonance
TransEsophageal Echocardiography and TransEsophageal Echocardiography
imaging as standard practice
Cardiac Magnetics Resonance
imaging as standard practice
Group C
TransEsophageal Echocardiography + TransThoracic Echocardiography + MitraClip
TransEsophageal Echocardiography and TransEsophageal Echocardiography
imaging as standard practice
MitraClip
imaging as standard practice
Interventions
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TransEsophageal Echocardiography and TransEsophageal Echocardiography
imaging as standard practice
Cardiac Magnetics Resonance
imaging as standard practice
MitraClip
imaging as standard practice
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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:
18 Years
85 Years
ALL
No
Sponsors
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Philips Electronics Nederland B.V. acting through Philips CTO organization
INDUSTRY
Responsible Party
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Locations
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Saint Luc University Hospital
Brussels, , Belgium
Countries
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Other Identifiers
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ICBE-2-15217
Identifier Type: -
Identifier Source: org_study_id