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European Association of Cardiovascular Imaging Multiple and Mixed Valvular Disease Study

European Association of Cardiovascular Imaging Multiple and Mixed Valvular Disease Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06235385
Acronym
EACVI-MMVD
Enrollment
1500
Registered
2024-01-31
Start date
2024-02-07
Completion date
2029-08-01
Last updated
2024-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Disease, Aortic Valve Insufficiency, Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency, Heart Valve Diseases, Mitral Valve Disease, Mitral Valve Disease Mixed, Mitral Valve Insufficiency, Mitral Valve Insufficiency and Aortic Valve Insufficiency, Mitral Valve Stenosis, Multiple Valve Disease, Unspecified, Tricuspid Stenosis, Tricuspid Valve Disease, Tricuspid Valve Insufficiency

Keywords

Multiple Valvular Heart Disease, Mixed Valvular Heart Disease

Brief 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. 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.

Interventions

OTHERIntervention not provided

This study is purely observational

Sponsors

European Association of Cardiovascular Imaging
CollaboratorOTHER
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Age ≥ 18 years 2. Patient referred to the cardiovascular imaging department. 3. Diagnosis of MMVD confirmed by transthoracic echocardiography, defined as: 1. Multiple VHD: at least 2 moderates to severe VHD involving ≥ 2 different valves, using the current ESC guidelines. and/or 2. Mixed VHD: at least moderate stenosis and at least moderate regurgitation of a single valve, using the current ESC guidelines. 4. 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): 1. History of prior valve surgery or percutaneous valve intervention (concerning a valve other than those involved in the definition of MMVD). 2. Acute infective endocarditis at the time of evaluation for inclusion (confirmed according to modified Duke criteria) or history of endocarditis ≤ 6 months. 3. Complex congenital heart diseases.

Design outcomes

Primary

MeasureTime frameDescription
Proportion of multiple and mixed valvular disease (MMVD)BaselineNumber 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

Secondary

MeasureTime frameDescription
Major Adverse Cardiovascular Event (MACE)Up to 5 yearsClinical composite outcome defined as: cardiovascular mortality, hospitalization for heart failure (HF), myocardial infarction, pulmonary embolism and stroke.
All-cause mortalityUp to 5 yearsThe adjudication of all-cause death was performed using the follow-up performed in clinical routine
Cardiovascular mortalityUp to 5 yearsThe adjudication of cardiovascular mortality was performed using the follow-up performed in clinical routine
Hospitalization for heart failureUp to 5 yearsHospitalization for heart failure according to the European Society of Cardiology (ESC) guidelines

Countries

France

Contacts

Primary ContactThéo PEZEL, MD PhD
theo.pezel@aphp.fr668722489
Backup ContactAlexandre UNGER, MD
alexandre.unger@ulb.be478487691

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026