Mitral Valve Regurgitation of Any GradeNCT03286088
Mitral Valve Regurgitation Quantification From 3D Color Doppler Ultrasound - Standard of Care Data Collection
A study testing TransEsophageal Echocardiography and TransEsophageal Echocardiography, Cardiac Magnetics Resonance and MitraClip in people with Mitral Valve Regurgitation of Any Grade, run by Philips Clinical & Medical Affairs Global at 1 site in Belgium.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Mitral Valve Regurgitation of Any Grade
- What is being tested?
- TransEsophageal Echocardiography and TransEsophageal Echocardiography, Cardiac Magnetics Resonance and MitraClip
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Aug 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- TransEsophageal Echocardiography and TransEsophageal Echocardiography, Cardiac Magnetics Resonance, MitraClip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TransEsophageal Echocardiography and TransEsophageal EchocardiographyDiagnostic test
imaging as standard practice
Cardiac Magnetics ResonanceDiagnostic test
imaging as standard practice
MitraClipDiagnostic test
imaging as standard practice
| Study group | Role | What they receive |
|---|---|---|
| Group A | Other | TransEsophageal Echocardiography + TransThoracic Echocardiography Receives: Diagnostic Test: TransEsophageal Echocardiography and TransEsophageal Echocardiography |
| Group B | Other | TransEsophageal Echocardiography + TransThoracic Echocardiography + cardiac Magnetic Resonance Receives: Diagnostic Test: TransEsophageal Echocardiography and TransEsophageal Echocardiography; Diagnostic Test: Cardiac Magnetics Resonance |
| Group C | Other | TransEsophageal Echocardiography + TransThoracic Echocardiography + MitraClip Receives: Diagnostic Test: TransEsophageal Echocardiography and TransEsophageal Echocardiography; Diagnostic Test: MitraClip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central diastolic and systolic blood pressures
images and measurements
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start22 Aug 2017
- Primary completion31 Jul 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve Regurgitation of Any GradeStudies of the same condition, open and under way.
- More trials run by Philips Clinical & Medical Affairs GlobalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03286088
- Sponsor's protocol ID
- ICBE-2-15217
- Status last verified
- Oct 2021
- First submitted
- 31 Mar 2017
- Last updated
- 27 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitral Valve Regurgitation Quantification From 3D Color Doppler Ultrasound - Standard of Care Data Collection
- ClinicalTrials.gov ID
- NCT03286088
- Acronym / sponsor ID
- ICBE-2-15217
- Conditions
- Mitral Valve Regurgitation of Any Grade
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- 22 Aug 2017 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 18 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Diagnostic Test: TransEsophageal Echocardiography and TransEsophageal EchocardiographyTransEsophageal Echocardiography + TransThoracic Echocardiography |
| Group B | Other | Diagnostic Test: TransEsophageal Echocardiography and TransEsophageal Echocardiography, Diagnostic Test: Cardiac Magnetics ResonanceTransEsophageal Echocardiography + TransThoracic Echocardiography + cardiac Magnetic Resonance |
| Group C | Other | Diagnostic Test: TransEsophageal Echocardiography and TransEsophageal Echocardiography, Diagnostic Test: MitraClipTransEsophageal Echocardiography + TransThoracic Echocardiography + MitraClip |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TransEsophageal Echocardiography and TransEsophageal Echocardiographyimaging as standard practice | Diagnostic test | Group A, Group B, Group C |
| Cardiac Magnetics Resonanceimaging as standard practice | Diagnostic test | Group B |
| MitraClipimaging as standard practice | Diagnostic test | Group C |
Primary outcome
Central diastolic and systolic blood pressures
Time frame: Day 1
images and measurements
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TransEsophageal Echocardiography and TransEsophageal Echocardiography, Cardiac Magnetics Resonance and MitraClip in people with Mitral Valve Regurgitation of Any Grade, run by Philips Clinical & Medical Affairs Global at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central diastolic and systolic blood pressures (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2021.