search
Back to results

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

Primary Purpose

Mitral Valve Regurgitation of Any Grade

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
TransEsophageal Echocardiography and TransEsophageal Echocardiography
Cardiac Magnetics Resonance
MitraClip
Sponsored by
Philips Electronics Nederland B.V. acting through Philips CTO organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mitral Valve Regurgitation of Any Grade

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Saint Luc University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Group A

Group B

Group C

Arm Description

TransEsophageal Echocardiography + TransThoracic Echocardiography

TransEsophageal Echocardiography + TransThoracic Echocardiography + cardiac Magnetic Resonance

TransEsophageal Echocardiography + TransThoracic Echocardiography + MitraClip

Outcomes

Primary Outcome Measures

Central diastolic and systolic blood pressures
images and measurements

Secondary Outcome Measures

Full Information

First Posted
March 31, 2017
Last Updated
October 26, 2021
Sponsor
Philips Electronics Nederland B.V. acting through Philips CTO organization
search

1. Study Identification

Unique Protocol Identification Number
NCT03286088
Brief Title
Mitral Valve Regurgitation Quantification From 3D Color Doppler Ultrasound - Standard of Care Data Collection
Official Title
Mitral Valve Regurgitation Quantification From 3D Color Doppler Ultrasound - Standard of Care Data Collection
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
August 22, 2017 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philips Electronics Nederland B.V. acting through Philips CTO organization

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Valve Regurgitation of Any Grade

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Other
Arm Description
TransEsophageal Echocardiography + TransThoracic Echocardiography
Arm Title
Group B
Arm Type
Other
Arm Description
TransEsophageal Echocardiography + TransThoracic Echocardiography + cardiac Magnetic Resonance
Arm Title
Group C
Arm Type
Other
Arm Description
TransEsophageal Echocardiography + TransThoracic Echocardiography + MitraClip
Intervention Type
Diagnostic Test
Intervention Name(s)
TransEsophageal Echocardiography and TransEsophageal Echocardiography
Intervention Description
imaging as standard practice
Intervention Type
Diagnostic Test
Intervention Name(s)
Cardiac Magnetics Resonance
Intervention Description
imaging as standard practice
Intervention Type
Diagnostic Test
Intervention Name(s)
MitraClip
Intervention Description
imaging as standard practice
Primary Outcome Measure Information:
Title
Central diastolic and systolic blood pressures
Description
images and measurements
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Saint Luc University Hospital
City
Brussels
ZIP/Postal Code
1200
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs