RecruitingNCT06235385

European Association of Cardiovascular Imaging Multiple and Mixed Valvular Disease Study


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

1,500 participants

Start Date

Feb 7, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria7

  • Age ≥ 18 years
  • Patient referred to the cardiovascular imaging department.
  • Diagnosis of MMVD confirmed by transthoracic echocardiography, defined as:
  • Multiple VHD: at least 2 moderates to severe VHD involving ≥ 2 different valves, using the current ESC guidelines.
  • and/or
  • Mixed VHD: at least moderate stenosis and at least moderate regurgitation of a single valve, using the current ESC guidelines.
  • Patient not refusing to have their data involved in the protocol after information.

Exclusion Criteria3

  • 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.

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Interventions

OTHERIntervention not provided

This study is purely observational


Locations(1)

Assistance Publique Hôpitaux de Paris

Paris, Île-de-France Region, France

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NCT06235385


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