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.

Study Overview

• Status: Completed
• Conditions: Mitral Valve Regurgitation of Any Grade
• Intervention / Treatment: Diagnostic test: TransEsophageal Echocardiography and TransEsophageal Echocardiography; Diagnostic test: Cardiac Magnetics Resonance; Diagnostic test: MitraClip

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Saint Luc University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group A; TransEsophageal Echocardiography + TransThoracic Echocardiography	Diagnostic test: TransEsophageal Echocardiography and TransEsophageal Echocardiography; imaging as standard practice
Other: Group B; TransEsophageal Echocardiography + TransThoracic Echocardiography + cardiac Magnetic Resonance	Diagnostic test: TransEsophageal Echocardiography and TransEsophageal Echocardiography; imaging as standard practice; Diagnostic test: Cardiac Magnetics Resonance; imaging as standard practice
Other: Group C; TransEsophageal Echocardiography + TransThoracic Echocardiography + MitraClip	Diagnostic test: TransEsophageal Echocardiography and TransEsophageal Echocardiography; imaging as standard practice; Diagnostic test: MitraClip; imaging as standard practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Central diastolic and systolic blood pressures	images and measurements	Day 1

Collaborators and Investigators

• Sponsor: Philips Electronics Nederland B.V. acting through Philips CTO organization

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2017
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: March 31, 2017
• First Submitted That Met QC Criteria: September 15, 2017
• First Posted (Actual): September 18, 2017

Study Record Updates

• Last Update Posted (Actual): October 27, 2021
• Last Update Submitted That Met QC Criteria: October 26, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: ICBE-2-15217

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No