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

French Cardiology Society

Status: Begins enrollment this month

Conditions: Valvular Heart Disease

Study type: Observational

Funder types: Other

Identifiers

NCT07176507

2023-A02626-39

Details and patient eligibility

About

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.

Full description

National, Prospective, Multicentric Registry. Patients with a diagnosis of MMVD identified by echocardiography will be included and followed up at 1, 2, 3 and 5 years.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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
• 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 design

1,000 participants in 1 patient group

Patients with a diagnosis of MMVD

Description:

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.