NCT03286088

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Philips Electronics Nederland B.V. acting through Philips CTO organization · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mitral Valve Regurgitation of Any Grade

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	TransEsophageal Echocardiography and TransEsophageal Echocardiography	imaging as standard practice
DIAGNOSTIC_TEST	Cardiac Magnetics Resonance	imaging as standard practice
DIAGNOSTIC_TEST	MitraClip	imaging as standard practice

Timeline

• Start date: 2017-08-22
• Primary completion: 2019-07-31
• Completion: 2019-12-31
• First posted: 2017-09-18
• Last updated: 2021-10-27

Locations

1 site across 1 country: Belgium