Valvular Heart DiseaseMULTIVALVENCT07176507
MULTIVALVE : A Prospective Multicentre Study of Multiple and Mixed Valvular Heart Disease
An observational study of Valvular Heart Disease, run by French Cardiology Society at 2 sites in France.
Trial summary
Multiple and mixed valvular heart disease (MMVD) is a common condition in clinical practice. It corresponds to a combination of stenotic or leaky lesions on two or more heart valves (multiple valve disease), or a combination of stenotic and leaky lesions on the same valve (mixed valve disease). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Valvular Heart Disease
- How many people
- 1,000 participants
- Where
- 2 sitesFrance
- Study dates
- 30 Oct 2025to Oct 2032
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a diagnosis of MMVD based on cardiovascular imaging and defined as follows: At least two cases of moderate to severe valvular heart disease, as assessed by a cardiologist and defined by transthoracic echocardiography (TTE) on one or more valves. This is in line with the recommendations of the European Society of Cardiology (ESC), the American Society of Echocardiography (ASE) and expert opinion.
Who may be able to join
- Age ≥18 years
- The patient has been informed of the study and has not refused to participate.
- An echocardiographic diagnosis of MMVD is defined as having at least two moderate to severe valvulopathies, as assessed by a cardiologist using transthoracic echocardiography (TTE), on one or more valves. This is in line with the recommendations of the ESC, the ASE, and expert opinion.
Who cannot join
- History of valve surgery or percutaneous valve intervention involving the valve in question.
- A history of infective endocarditis, whether treated surgically or not, confirmed according to the modified Duke criteria.
- Acute infective endocarditis at the time of evaluation for inclusion, confirmed according to the modified Duke criteria.
- Complex congenital heart disease.
- Patients who are already included in the European EACVI-MMVD study.
- Pregnant women
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- Patients not affiliated to social security
- Patients who are minors
- Patients under guardianship, curatorship or judicial supervision
- Patients who refuse to participate in this register.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Chu Lille- Hopital Cardiologique
Lille
Augustin COISNE, 01 44 90 70 28, multivalve@sfcardio.fr
- Recruiting
Chu Lariboisiere (Aphp)
Paris
Théo PEZEL, 01 44 90 70 28, multivalve@sfcardio.fr
About this study
Multiple and mixed valvular heart disease (MMVD) is a common condition in clinical practice. It corresponds to a combination of stenotic or leaky lesions on two or more heart valves (multiple valve disease), or a combination of stenotic and leaky lesions on the same valve (mixed valve disease). However, the management of their clinical, biological and cardiovascular imaging is not well established. Current European Society of Cardiology (ESC) recommendations primarily address the various valve diseases in isolation. This results in an absence of reliable recommendations for managing MMVD, with different approaches being adopted by care centres.
In order to address this knowledge gap regarding MMVD, it is crucial to assess its prevalence, the cardiovascular imaging methods employed and the management strategies, as well as to identify prognostic factors for the various combinations of valve disease.
The multicentre MMVD study will be a valuable resource as it will improve our understanding of the prognosis for patients with MMVD. It will highlight imaging and biological markers associated with the prognosis of different combinations of MMVD.
Read the detailed description
National, Prospective, Multicentric Registry. Patients with a diagnosis of MMVD identified by echocardiography will be included and followed up at 1, 2, 3, 4 and 5 years.
- Conditions
- Valvular Heart Disease
- Keywords
- valvular heart disease, Multiple and mixed valvular heart disease, multiple valve disease
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with a diagnosis of MMVD | Patients with a diagnosis of MMVD based on cardiovascular imaging and defined as follows: At least two cases of moderate to severe valvular heart disease, as assessed by a cardiologist and defined by transthoracic echocardiography (TTE) on one or more valves. This is in line with the recommendations of the European Society of Cardiology (ESC), the American Society of Echocardiography (ASE) and expert opinion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the association between cardiovascular imaging parameters (echocardiography and cardiac MRI) and cardiovascular event-free survival in a population of MMVD.
Survival without cardiovascular event
Measured: 1 year after inclusion
Secondary outcomes (11)
To assess the association between cardiovascular imaging parameters and survival
Measured: at 1, 2, 3, 4 and 5 years after inclusion
Proportion of patients who did not experience a cardiovascular event
Measured: at 1, 2, 3, 4 and 5 years after inclusion
Proportion of patients who are alive
Measured: at 1, 2, 3, 4 and 5 years after inclusion
Proportion of patients who did not experience a cardiovascular event depending on the type of treatment (medical, surgical or percutaneous)
Measured: at 1, 2, 3, 4 and 5 years after inclusion
Proportion of patients who are alive depending on the type of treatment (medical, surgical or percutaneous)
Measured: at 1, 2, 3, 4 and 5 years after inclusion
To assess the progression of the stage of severity of valvulopathy
Echocardiography
Measured: at 1, 2, 3, 4 and 5 years after inclusion
% of patients with MMVD combinations
Measured: during 5 years after inclusion
Measurement of cardiovascular biomarkers
BNP or NT-pro-BNP and troponin
Measured: at baseline and 1, 2, 3, 4 and 5 years after inclusion
Assessing the association between cardiovascular biomarkers in patients with MMVD and survival
BNP or NT-pro-BNP and troponin, vital status
Measured: during 5 years after inclusion
Assessing the association between cardiovascular biomarkers in patients with MMVD and cardiovascular event-free survival
BNP or NT-pro-BNP and troponin, Survival without cardiovascular event
Measured: during 5 years after inclusion
Exploring the value of cardiovascular biomarkers analysed in a centralised laboratory (optional)
Biobank (optional)
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start30 Oct 2025
- Primary completionOct 2028 (estimated)
- Study completionOct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valvular Heart DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07176507
- Sponsor's protocol ID
- 2023-A02626-39
- Acronym
- MULTIVALVE
- Status last verified
- Jun 2026
- First submitted
- 24 Jul 2025
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MULTIVALVE : A Prospective Multicentre Study of Multiple and Mixed Valvular Heart Disease
- ClinicalTrials.gov ID
- NCT07176507
- Acronym / sponsor ID
- MULTIVALVE / 2023-A02626-39
- Conditions
- Valvular Heart Disease
- Keywords
- valvular heart disease, Multiple and mixed valvular heart disease, multiple valve disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2032 (estimated)
- First posted
- 16 Sep 2025 (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.
Multiple and mixed valvular heart disease (MMVD) is a common condition in clinical practice. It corresponds to a combination of stenotic or leaky lesions on two or more heart valves (multiple valve disease), or a combination of stenotic and leaky lesions on the same valve (mixed valve disease). However, the management of their clinical, biological and cardiovascular imaging is not well established. Current European Society of Cardiology (ESC) recommendations primarily address the various valve diseases in isolation. This results in an absence of reliable recommendations for managing MMVD, with different approaches being adopted by care centres.
In order to address this knowledge gap regarding MMVD, it is crucial to assess its prevalence, the cardiovascular imaging methods employed and the management strategies, as well as to identify prognostic factors for the various combinations of valve disease.
The multicentre MMVD study will be a valuable resource as it will improve our understanding of the prognosis for patients with MMVD. It will highlight imaging and biological markers associated with the prognosis of different combinations of MMVD.
Detailed description
National, Prospective, Multicentric Registry. Patients with a diagnosis of MMVD identified by echocardiography will be included and followed up at 1, 2, 3, 4 and 5 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with a diagnosis of MMVD | – | –Patients with a diagnosis of MMVD based on cardiovascular imaging and defined as follows: At least two cases of moderate to severe valvular heart disease, as assessed by a cardiologist and defined by transthoracic echocardiography (TTE) on one or more valves. This is in line with the recommendations of the European Society of Cardiology (ESC), the American Society of Echocardiography (ASE) and expert opinion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of MMVD based on cardiovascular imaging and defined as follows: At least two cases of moderate to severe valvular heart disease, as assessed by a cardiologist and defined by transthoracic echocardiography (TTE) on one or more valves. This is in line with the recommendations of the European Society of Cardiology (ESC), the American Society of Echocardiography (ASE) and expert opinion.
Key inclusion criteria (3 listed)
- Age ≥18 years
- The patient has been informed of the study and has not refused to participate.
- An echocardiographic diagnosis of MMVD is defined as having at least two moderate to severe valvulopathies, as assessed by a cardiologist using transthoracic echocardiography (TTE), on one or more valves. This is in line with the recommendations of the ESC, the ASE, and expert opinion.
Key exclusion criteria (10 listed)
- History of valve surgery or percutaneous valve intervention involving the valve in question.
- A history of infective endocarditis, whether treated surgically or not, confirmed according to the modified Duke criteria.
- Acute infective endocarditis at the time of evaluation for inclusion, confirmed according to the modified Duke criteria.
- Complex congenital heart disease.
- Patients who are already included in the European EACVI-MMVD study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess the association between cardiovascular imaging parameters (echocardiography and cardiac MRI) and cardiovascular event-free survival in a population of MMVD.
Time frame: 1 year after inclusion
Survival without cardiovascular event
11 secondary outcomes
To assess the association between cardiovascular imaging parameters and survival
Time frame: at 1, 2, 3, 4 and 5 years after inclusion
Proportion of patients who did not experience a cardiovascular event
Time frame: at 1, 2, 3, 4 and 5 years after inclusion
Proportion of patients who are alive
Time frame: at 1, 2, 3, 4 and 5 years after inclusion
Proportion of patients who did not experience a cardiovascular event depending on the type of treatment (medical, surgical or percutaneous)
Time frame: at 1, 2, 3, 4 and 5 years after inclusion
Proportion of patients who are alive depending on the type of treatment (medical, surgical or percutaneous)
Time frame: at 1, 2, 3, 4 and 5 years after inclusion
To assess the progression of the stage of severity of valvulopathy
Time frame: at 1, 2, 3, 4 and 5 years after inclusion
% of patients with MMVD combinations
Time frame: during 5 years after inclusion
Measurement of cardiovascular biomarkers
Time frame: at baseline and 1, 2, 3, 4 and 5 years after inclusion
Assessing the association between cardiovascular biomarkers in patients with MMVD and survival
Time frame: during 5 years after inclusion
Assessing the association between cardiovascular biomarkers in patients with MMVD and cardiovascular event-free survival
Time frame: during 5 years after inclusion
Exploring the value of cardiovascular biomarkers analysed in a centralised laboratory (optional)
Time frame: at baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Valvular Heart Disease, run by French Cardiology Society at 2 sites in France.
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 3 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Théo PEZEL (01 44 90 70 28 ext. +33, multivalve@sfcardio.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the association between cardiovascular imaging parameters (echocardiography and cardiac MRI) and cardiovascular event-free survival in a population of MMVD. (time frame: 1 year after inclusion). 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 12 Jun 2026.