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OpenTrials
Completed

NCT Number: NCT03286088

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.

Completed

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Key information

Conditions

Mitral Valve Regurgitation of Any Grade

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint Luc University Hospital

Brussels, 1200, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TransEsophageal Echocardiography and TransEsophageal Echocardiography

Diagnostic Test

imaging as standard practice

Cardiac Magnetics Resonance

Diagnostic Test

imaging as standard practice

MitraClip

Diagnostic Test

imaging as standard practice

Primary outcomes

  1. Central diastolic and systolic blood pressures

    Time frame: Day 1

    images and measurements

Sponsors and collaborators

Lead sponsor

Philips Electronics Nederland B.V. acting through Philips CTO organization

Industry

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 18, 2017
Registry last updated
Oct 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.