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

Philips

Status: Completed

Conditions: Mitral Valve Regurgitation of Any Grade

Treatments: Diagnostic Test: Cardiac Magnetics Resonance; Diagnostic Test: MitraClip; Diagnostic Test: TransEsophageal Echocardiography and TransEsophageal Echocardiography

Study type: Interventional

Funder types: Industry

Identifiers

NCT03286088

ICBE-2-15217

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Group A

Other group

Description:

TransEsophageal Echocardiography + TransThoracic Echocardiography

Treatment:

Diagnostic Test: TransEsophageal Echocardiography and TransEsophageal Echocardiography

Group B

Other group

Description:

TransEsophageal Echocardiography + TransThoracic Echocardiography + cardiac Magnetic Resonance

Treatment:

Diagnostic Test: Cardiac Magnetics Resonance

Diagnostic Test: TransEsophageal Echocardiography and TransEsophageal Echocardiography

Group C

Other group

Description:

TransEsophageal Echocardiography + TransThoracic Echocardiography + MitraClip

Treatment:

Diagnostic Test: MitraClip

Diagnostic Test: TransEsophageal Echocardiography and TransEsophageal Echocardiography