NCT03286088

Completed

Mitral Valve Regurgitation Quantification From 3D Color Dopp...

Philips Clinical & Medical Affairs Global Source

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Other study identifiers

Sponsor study identifier

ICBE-2-15217

Study Type

interventional

Actual enrollment (reported)

120

Locations

1 country

Sites

1

Timeline

Study Start

August 22, 2017

Actual (reported)

Primary Completion

July 31, 2019

Actual (reported)

Study Completion

December 31, 2019

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 120 participants
Study completion date: December 31, 2019
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
March 31, 2017
Actual (reported)
Study Start
August 22, 2017
Actual (reported)
First Posted
September 18, 2017
Actual (reported)
Primary Completion
July 31, 2019
Actual (reported)
Study Completion
December 31, 2019
Actual (reported)

Last Updated: October 27, 2021
Status Verified: October 2021
Last Update Submitted: October 26, 2021

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 EchocardiographyDiagnostic Test: Cardiac Magnetics Resonance

Group C

OTHER

Interventions

TransEsophageal Echocardiography and TransEsophageal EchocardiographyDiagnostic test

imaging as standard practice

Group AGroup BGroup C

Cardiac Magnetics ResonanceDiagnostic test

imaging as standard practice

Eligibility Criteria

Age18 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

both genders
age between 18 and 85 years old (adult, senior)

Sponsors & Collaborators

Philips Clinical & Medical Affairs Global
Industrylead

Study Sites (1)

Saint Luc University Hospital

Brussels, 1200, Belgium

MeSH Terms

Interventions

Echocardiography, Transesophageal

Intervention Hierarchy (Ancestors)

EchocardiographyCardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Enrollment

120 participants (actual enrollment reported by the registry).

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

Actual (reported)

Not Applicable

Completed

NCT05292716

Mitral Regurgitation Treatment in Advanced Heart Failure

Not ApplicableUnknown

NCT06282042

Early Transcatheter Mitral Valve Repair After Myocardial Infarction

Not ApplicableRecruiting

NCT04293575

Transcatheter Mitral Valve Repair as Bridge Therapy to Heart Transplantation

Unknown

NCT02506387

Belgian Mitraclip Registry

Completed

NCT03521921

GIse Registry Of Transcatheter Treatment of Mitral Valve regurgitaTiOn (GIOTTO)

Unknown

NCT03107455

MitraClip in Acute Mitral Regurgitation

Completed

TransEsophageal Echocardiography + TransThoracic Echocardiography + MitraClip

Diagnostic Test: TransEsophageal Echocardiography and TransEsophageal EchocardiographyDiagnostic Test: MitraClip

Group B

MitraClipDiagnostic test

imaging as standard practice

Group C

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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:

Contact the study team to confirm eligibility.

Primary Completion

July 31, 2019

Actual (reported)

Study Completion

December 31, 2019

Actual (reported)

Last Updated

October 27, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT03286088
Data provider: ClinicalTrials.gov
Source updated: 2021-10-27
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:22:54 UTC

Locations

BE(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (3)

Group A

Group B

Group C

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations