Heart Valve DiseasesEACVI-MMVDNCT06235385
European Association of Cardiovascular Imaging Multiple and Mixed Valvular Disease Study
An observational study of Heart Valve Diseases and Multiple Valve Disease, Unspecified, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This study aims to investigate the prevalence and characteristics of multiple and mixed valvular heart disease (MMVD), which includes combinations of stenotic or regurgitant lesions on cardiac valves. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Valve Diseases, Multiple Valve Disease, Unspecified, Aortic Valve Disease
- What is being tested?
- Intervention not provided
- How many people
- 1,500 participants
- Where
- 1 siteFrance
- Study dates
- 7 Feb 2024to 1 Aug 2029
- 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: All patients referred to a Cardiovascular imaging Department with a diagnosis of at least one at least moderate VHD, and who meet the criteria for MMVD defined by multiple and/or mixed disease, will be included in the study.
Who may be able to join
- Age ≥ 18 years
- Patient referred to the cardiovascular imaging department.
- Diagnosis of MMVD confirmed by transthoracic echocardiography, defined as:
- Multiple VHD: at least 2 moderates to severe VHD involving ≥ 2 different valves, using the current ESC guidelines.
- and/or
- Mixed VHD: at least moderate stenosis and at least moderate regurgitation of a single valve, using the current ESC guidelines.
Show all 11Show fewer
- Patient not refusing to have their data involved in the protocol after information.
- Exclusion Criteria (patients fulfilling any of the following criteria are not eligible for inclusion in this study):
- History of prior valve surgery or percutaneous valve intervention (concerning a valve other than those involved in the definition of MMVD).
- Acute infective endocarditis at the time of evaluation for inclusion (confirmed according to modified Duke criteria) or history of endocarditis ≤ 6 months.
- Complex congenital heart diseases.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hôpitaux de Paris
Paris, Île-de-France Region, 75010
Théo PEZEL, MD PhD, 668722489 ext. +33, theo.pezel@aphp.fr
Alexandre UNGER, MD, 478487691 ext. +32, alexandre.unger@ulb.be
About this study
This study aims to investigate the prevalence and characteristics of multiple and mixed valvular heart disease (MMVD), which includes combinations of stenotic or regurgitant lesions on cardiac valves. The research will be conducted as a multicenter observational study, involving several centers worldwide, and will have a one-year follow-up period (with a possible extension to 5 years). The primary aim is to determine the proportion of MMVD among patients evaluated for valvular heart disease. Secondary aims include the evaluation of the epidemiologic distribution of clinical, biological, and cardiovascular imaging characteristics at baseline, management strategies, and their impact on prognosis. The study will also evaluate clinical outcomes such as mortality, hospitalization for heart failure, and changes in echocardiographic parameters. This research aims to provide valuable insights into the diagnosis, management, and prognosis of MMVD, addressing an important knowledge gap in this area.
Read the detailed description
Multiple and mixed valvular heart disease (MMVD), ie, the combination of stenotic or regurgitant lesions occurring on ≥2 cardiac valves (multiple valvular heart disease (VHD)) or the combination of stenotic and regurgitant lesions on the same valve (mixed VHD), are frequent in clinical routine. Nevertheless, their clinical, biological, cardiovascular imaging, and management is not well established.
This study will assess the proportion of MMVD including each combination of multiple and mixed VHD in a multicentre registry of all consecutive patients assessed on a cardiovascular imaging department for VHD. Furthermore, as secondary aims, baseline characteristics, decision-making and therapeutic strategy at baseline and their impact in terms of prognostic.
This is a prospective multicentre observational study involving 174 centres worldwide (35 countries) conducted as a cohort study with a 1-year follow-up (with possible extension to 5 years). Consecutive patients with a diagnosis of MMVD by echocardiography who meet the inclusion criteria will be included during the 6 months period of recruitment. In the context of a "real-life" cohort, baseline evaluation will be left to the discretion of the attending physician (and could encompass clinical evaluations, biomarkers, electrocardiograms, transthoracic and transoesophageal echocardiography, stress echocardiography, cardiac catheterization, invasive angiography, cardiac CT, and Cardiac MRI). Final diagnosis of the physician will be given, and physician will manage the patient in accordance with international guidelines (transcatheter valve intervention, surgery or no intervention). One year follow-up will be performed during a patient visit or by contact with the treating physician or the patient: vital status, hospitalizations for cardiac reasons (including heart failure), history of stroke and the performance of a new valvular intervention.
The primary endpoint will be the proportion of MMVD among all patients admitted for VHD evaluation in the imaging department. Secondary endpoints encompass; (i) epidemiologic distribution of clinical, biological, and cardiovascular imaging characteristics at baseline. (ii) proportion of MMVD treated by surgery, percutaneous or medical as well as the detail for management and how complication are managed (iii) prognostic evaluation at one year of follow-up in terms of clinical composite outcome (cardiovascular mortality, hospitalization for heart failure, myocardial infarction, pulmonary embolism and stroke), all-cause mortality, hospitalisation for heart failure, and change in echocardiographic parameters.
This is the first prospective multicentre study assessing the proportion of MMVD and their characteristics in term of diagnosis, management, and prognostic.
- Conditions
- Heart Valve Diseases, Multiple Valve Disease, Unspecified, Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Insufficiency, Mitral Valve Disease
- Being tested
- Intervention not provided
- Keywords
- Multiple Valvular Heart Disease, Mixed Valvular Heart Disease
- Medical subject headings
- Heart Valve Diseases, Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Insufficiency, Mitral Valve Stenosis, Mitral Valve Insufficiency, Tricuspid Valve Insufficiency, Tricuspid Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention not providedOther
This study is purely observational
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of multiple and mixed valvular disease (MMVD)
Number of consecutive patients diagnosed with multiple and mixed valvular disease divided by the total number of consecutive patients assessed for valvular heart disease on a cardiovascular imaging department
Measured: Baseline
Secondary outcomes (4)
Major Adverse Cardiovascular Event (MACE)
Clinical composite outcome defined as: cardiovascular mortality, hospitalization for heart failure (HF), myocardial infarction, pulmonary embolism and stroke.
Measured: Up to 5 years
All-cause mortality
The adjudication of all-cause death was performed using the follow-up performed in clinical routine
Measured: Up to 5 years
Cardiovascular mortality
The adjudication of cardiovascular mortality was performed using the follow-up performed in clinical routine
Measured: Up to 5 years
Hospitalization for heart failure
Hospitalization for heart failure according to the European Society of Cardiology (ESC) guidelines
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start7 Feb 2024
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Valve DiseasesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- European Association of Cardiovascular Imaging
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06235385
- Sponsor's protocol ID
- AP-HP : 231784
- Acronym
- EACVI-MMVD
- Status last verified
- May 2024
- First submitted
- 23 Jan 2024
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data cannot be shared for ethical/privacy reasons. The data cannot be shared publicly for the privacy of individuals that participated in the study and also because of regulatory constraints in the field of clinical research in France, it is unfortunately not possible to make the entire database available to all as an open source.
Publications
Unger A, Mandoli GE, Neglia D, Romero Dorta E, Kagiyama N, Borodzicz-Jazdzyk S, Velegraki E, Coisne A, Uygur B, Afana A, Florence J, Bohbot Y, Donal E, Clavel MA, Pibarot P, Unger P, Manka R, Nijveldt R, Gimelli A, Gerber B, Dweck M, Muraru D, Pontone G, Ajmone Marsan N, Timoteo AT, Toupin S, Pereira C, Cosyns B, Vicaut E, Delgado V, Petersen S, Pezel T. Rational and design of EACVI-MMVD study: an international registry on multimodality imaging for mixed and multiple valvular heart disease. Eur Heart J Imaging Methods Pract. 2026 Feb 2;4(1):qyaf156. doi: 10.1093/ehjimp/qyaf156. eCollection 2026 Jan.
PubMed 41635678
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Association of Cardiovascular Imaging Multiple and Mixed Valvular Disease Study
- ClinicalTrials.gov ID
- NCT06235385
- Acronym / sponsor ID
- EACVI-MMVD / AP-HP : 231784
- Conditions
- Heart Valve Diseases, Multiple Valve Disease, Unspecified, Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Insufficiency, Mitral Valve Disease
- Keywords
- Multiple Valvular Heart Disease, Mixed Valvular Heart Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- European Association of Cardiovascular Imaging
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 31 Jan 2024 (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.
This study aims to investigate the prevalence and characteristics of multiple and mixed valvular heart disease (MMVD), which includes combinations of stenotic or regurgitant lesions on cardiac valves. The research will be conducted as a multicenter observational study, involving several centers worldwide, and will have a one-year follow-up period (with a possible extension to 5 years). The primary aim is to determine the proportion of MMVD among patients evaluated for valvular heart disease. Secondary aims include the evaluation of the epidemiologic distribution of clinical, biological, and cardiovascular imaging characteristics at baseline, management strategies, and their impact on prognosis. The study will also evaluate clinical outcomes such as mortality, hospitalization for heart failure, and changes in echocardiographic parameters. This research aims to provide valuable insights into the diagnosis, management, and prognosis of MMVD, addressing an important knowledge gap in this area.
Detailed description
Multiple and mixed valvular heart disease (MMVD), ie, the combination of stenotic or regurgitant lesions occurring on ≥2 cardiac valves (multiple valvular heart disease (VHD)) or the combination of stenotic and regurgitant lesions on the same valve (mixed VHD), are frequent in clinical routine. Nevertheless, their clinical, biological, cardiovascular imaging, and management is not well established.
This study will assess the proportion of MMVD including each combination of multiple and mixed VHD in a multicentre registry of all consecutive patients assessed on a cardiovascular imaging department for VHD. Furthermore, as secondary aims, baseline characteristics, decision-making and therapeutic strategy at baseline and their impact in terms of prognostic.
This is a prospective multicentre observational study involving 174 centres worldwide (35 countries) conducted as a cohort study with a 1-year follow-up (with possible extension to 5 years). Consecutive patients with a diagnosis of MMVD by echocardiography who meet the inclusion criteria will be included during the 6 months period of recruitment. In the context of a "real-life" cohort, baseline evaluation will be left to the discretion of the attending physician (and could encompass clinical evaluations, biomarkers, electrocardiograms, transthoracic and transoesophageal echocardiography, stress echocardiography, cardiac catheterization, invasive angiography, cardiac CT, and Cardiac MRI). Final diagnosis of the physician will be given, and physician will manage the patient in accordance with international guidelines (transcatheter valve intervention, surgery or no intervention). One year follow-up will be performed during a patient visit or by contact with the treating physician or the patient: vital status, hospitalizations for cardiac reasons (including heart failure), history of stroke and the performance of a new valvular intervention.
The primary endpoint will be the proportion of MMVD among all patients admitted for VHD evaluation in the imaging department. Secondary endpoints encompass; (i) epidemiologic distribution of clinical, biological, and cardiovascular imaging characteristics at baseline. (ii) proportion of MMVD treated by surgery, percutaneous or medical as well as the detail for management and how complication are managed (iii) prognostic evaluation at one year of follow-up in terms of clinical composite outcome (cardiovascular mortality, hospitalization for heart failure, myocardial infarction, pulmonary embolism and stroke), all-cause mortality, hospitalisation for heart failure, and change in echocardiographic parameters.
This is the first prospective multicentre study assessing the proportion of MMVD and their characteristics in term of diagnosis, management, and prognostic.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients referred to a Cardiovascular imaging Department with a diagnosis of at least one at least moderate VHD, and who meet the criteria for MMVD defined by multiple and/or mixed disease, will be included in the study.
Key inclusion criteria (11 listed)
- Age ≥ 18 years
- Patient referred to the cardiovascular imaging department.
- Diagnosis of MMVD confirmed by transthoracic echocardiography, defined as:
- and/or
- Patient not refusing to have their data involved in the protocol after information.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Intervention not providedThis study is purely observational | Other | – |
Primary outcome
Proportion of multiple and mixed valvular disease (MMVD)
Time frame: Baseline
Number of consecutive patients diagnosed with multiple and mixed valvular disease divided by the total number of consecutive patients assessed for valvular heart disease on a cardiovascular imaging department
4 secondary outcomes
Major Adverse Cardiovascular Event (MACE)
Time frame: Up to 5 years
All-cause mortality
Time frame: Up to 5 years
Cardiovascular mortality
Time frame: Up to 5 years
Hospitalization for heart failure
Time frame: Up to 5 years
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 3 Jun 2024.
- Derived from this study: PubMed 41635678Unger A, Mandoli GE, Neglia D, Romero Dorta E, Kagiyama N, Borodzicz-Jazdzyk S, Velegraki E, Coisne A, Uygur B, Afana A, Florence J, Bohbot Y, Donal E, Clavel MA, Pibarot P, Unger P, Manka R, Nijveldt R, Gimelli A, Gerber B, Dweck M, Muraru D, Pontone G, Ajmone Marsan N, Timoteo AT, Toupin S, Pereira C, Cosyns B, Vicaut E, Delgado V, Petersen S, Pezel T. Rational and design of EACVI-MMVD study: an international registry on multimodality imaging for mixed and multiple valvular heart disease. Eur Heart J Imaging Methods Pract. 2026 Feb 2;4(1):qyaf156. doi: 10.1093/ehjimp/qyaf156. eCollection 2026 Jan.
- Individual participant dataSharing planned: No. Data cannot be shared for ethical/privacy reasons. The data cannot be shared publicly for the privacy of individuals that participated in the study and also because of regulatory constraints in the field of clinical research in France, it is unfortunately not possible to make the entire database available to all as an open source.
Related trials for Heart Valve Diseases
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
RecruitingObservational study
A Post-Market Assessment of the Safety and Performance of the TriClip™ System
Tricuspid Regurgitation (TR)
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Valve Diseases and Multiple Valve Disease, Unspecified, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 11 inclusion and 0 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 3 Jun 2024. 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 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, MD PhD (668722489 ext. +33, theo.pezel@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of multiple and mixed valvular disease (MMVD) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06235385, which also lists 1 linked publication.
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 3 Jun 2024.