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

NCT03286088 | Completed

• 1 other identifier: ICBE-2-15217
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Mitral Valve Regurgitation of Any Grade

Outcome Measures

Primary Outcomes (1)

• Central diastolic and systolic blood pressures

  images and measurements

  Day 1

Study Arms (3)

Group A

OTHER

TransEsophageal Echocardiography + TransThoracic Echocardiography

Diagnostic Test: TransEsophageal Echocardiography and TransEsophageal Echocardiography

Group B

OTHER

TransEsophageal Echocardiography + TransThoracic Echocardiography + cardiac Magnetic Resonance

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

Group C

OTHER

TransEsophageal Echocardiography + TransThoracic Echocardiography + MitraClip

Diagnostic Test: TransEsophageal Echocardiography and TransEsophageal Echocardiography; Diagnostic Test: MitraClip

Interventions

TransEsophageal Echocardiography and TransEsophageal Echocardiography DIAGNOSTIC_TEST

imaging as standard practice

Group A; Group B; Group C

Cardiac Magnetics Resonance DIAGNOSTIC_TEST

imaging as standard practice

Group B

MitraClip DIAGNOSTIC_TEST

imaging as standard practice

Group C

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

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

Study Sites (1)

Saint Luc University Hospital

Brussels, 1200, Belgium

Location

MeSH Terms

Interventions

Echocardiography, Transesophageal

Intervention Hierarchy (Ancestors)

Echocardiography; Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2017
• First Posted: September 18, 2017
• Study Start: August 22, 2017
• Primary Completion: July 31, 2019
• Study Completion: December 31, 2019
• Last Updated: October 27, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)