MULTIVALVE : A Prospective Multicentre Study of Multiple and Mixed Valvular Heart Disease

NCT07176507 | Not Yet Recruiting

• 1 other identifier: 2023-A02626-39
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

Brief 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). 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.

Conditions

Valvular Heart Disease

Keywords

valvular heart disease; Multiple and mixed valvular heart disease; multiple valve disease

Outcome Measures

Primary Outcomes (1)

• To assess the association between cardiovascular imaging parameters (echocardiography and/or cardiac MRI) and cardiovascular event-free survival in a population of MMVD.

  Survival without cardiovascular event

  1 year after inclusion

Secondary Outcomes (11)

• To assess the association between cardiovascular imaging parameters and survival

  at 1, 2, 3 and 5 years after inclusion

• Proportion of patients who did not experience a cardiovascular event

  at 1, 2, 3 and 5 years after inclusion

• Proportion of patients who are alive

  at 1, 2, 3 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)

  at 1, 2, 3 and 5 years after inclusion

• Proportion of patients who are alive depending on the type of treatment (medical, surgical or percutaneous)

  at 1, 2, 3 and 5 years after inclusion

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Complex congenital heart disease.
• Patients who are already included in the European EACVI-MMVD study.
• Pregnant women
• 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.

Sponsors & Collaborators

• French Cardiology Society: lead

Study Sites (2)

Chu Lille- Hopital Cardiologique

Lille, France

Location

Chu Lariboisiere (Aphp)

Paris, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

optional blood sample \<56ml

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Théo PEZEL

CONTACT

01 44 90 70 28; multivalve@sfcardio.fr

Augustin COISNE

CONTACT

01 44 90 70 28; multivalve@sfcardio.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: September 16, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2032
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

FR (2)