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European Association of Cardiovascular Imaging Multiple and Mixed Valvular Disease Study

ConditionsHeart Valve DiseasesMultiple Valve Disease, UnspecifiedAortic Valve DiseaseAortic Valve StenosisAortic Valve InsufficiencyMitral Valve DiseaseMitral Valve StenosisMitral Valve Insufficiency and Aortic Valve InsufficiencyMitral Valve InsufficiencyAortic Valve Stenosis With InsufficiencyMitral Valve Disease MixedTricuspid Valve InsufficiencyTricuspid Valve DiseaseTricuspid Stenosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Patient referred to the cardiovascular imaging department.

Multiple VHD: at least 2 moderates to severe VHD involving ≥ 2 different valves, using the current ESC guidelines.

Mixed VHD: at least moderate stenosis and at least moderate regurgitation of a single valve, using the current ESC guidelines.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Intervention not provided

    Other intervention

    This study is purely observational

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline

Secondary outcomes

1

Major Adverse Cardiovascular Event (MACE)

Clinical composite outcome defined as: cardiovascular mortality, hospitalization for heart failure (HF), myocardial infarction, pulmonary embolism and stroke.

Time frame
Up to 5 years
2

All-cause mortality

The adjudication of all-cause death was performed using the follow-up performed in clinical routine

Time frame
Up to 5 years
3

Cardiovascular mortality

The adjudication of cardiovascular mortality was performed using the follow-up performed in clinical routine

Time frame
Up to 5 years
4

Hospitalization for heart failure

Hospitalization for heart failure according to the European Society of Cardiology (ESC) guidelines

Time frame
Up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

European Association of Cardiovascular Imaging

Collaborator

Source ClinicalTrials.gov
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