European Association of Cardiovascular Imaging Multiple and Mixed Valvular Disease Study

NCT06235385 · tracked via the Priya Life Science France tracker

Sponsor

Assistance Publique - Hôpitaux de Paris

Phase

Observational

Started

2024-02-07

Last updated

2024-06-03

Condition(s) studied

Heart 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

Investigational drug(s) / intervention(s)

Intervention not provided

Intervention not provided: This study is purely observational

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Proportion of multiple and mixed valvular disease (MMVD) — Baseline
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

Trial sites (1)

Facility	City	Region	Status
Assistance Publique Hôpitaux de Paris	Paris	Île-de-France Region	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06235385 on ClinicalTrials.gov ↗ ← All trials in France