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

Not Applicable

Completed

• Conditions: Mitral Valve Regurgitation of Any Grade
• Interventions: Diagnostic Test: TransEsophageal Echocardiography and TransEsophageal Echocardiography; Diagnostic Test: MitraClip; Diagnostic Test: Cardiac Magnetics Resonance

• Registration Number: NCT03286088
• Lead Sponsor: Philips Electronics Nederland B.V. acting through Philips CTO organization

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-31
• Study Start: 2017-08-22
• Study First Submitted QC: 2017-09-15
• Study First Posted: 2017-09-18
• Primary Completion: 2019-07-31
• Study Completion: 2019-12-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-26
• Last Update Posted: 2021-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	TransEsophageal Echocardiography and TransEsophageal Echocardiography	TransEsophageal Echocardiography + TransThoracic Echocardiography + cardiac Magnetic Resonance
Group A	TransEsophageal Echocardiography and TransEsophageal Echocardiography	TransEsophageal Echocardiography + TransThoracic Echocardiography
Group C	TransEsophageal Echocardiography and TransEsophageal Echocardiography	TransEsophageal Echocardiography + TransThoracic Echocardiography + MitraClip
Group C	MitraClip	TransEsophageal Echocardiography + TransThoracic Echocardiography + MitraClip
Group B	Cardiac Magnetics Resonance	TransEsophageal Echocardiography + TransThoracic Echocardiography + cardiac Magnetic Resonance

Primary Outcome Measures

Name	Time	Method
Central diastolic and systolic blood pressures	Day 1	images and measurements

Trial Locations

Locations (1)

Saint Luc University Hospital; 🇧🇪 Brussels, Belgium