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

NCT ID: NCT07176507

Last Updated: 2025-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-31

Study Completion Date

2032-10-31

Brief Summary

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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

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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.

Conditions

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Valvular Heart Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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French Cardiology Society

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu Lille- Hopital Cardiologique

Lille, , France

Site Status

Chu Lariboisiere (Aphp)

Paris, , France

Site Status

Countries

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France

Central Contacts

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Théo PEZEL

Role: CONTACT

01 44 90 70 28 ext. +33

Augustin COISNE

Role: CONTACT

01 44 90 70 28 ext. +33

Facility Contacts

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Augustin COISNE

Role: primary

01 44 90 70 28

Théo PEZEL

Role: primary

01 44 90 70 28

Other Identifiers

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2023-A02626-39

Identifier Type: -

Identifier Source: org_study_id

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