European Association of Cardiovascular Imaging Multiple and Mixed Valvular Disease Study

NCT06235385 | Recruiting

• 1 other identifier: AP-HP : 231784
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Multiple Valvular Heart Disease; Mixed Valvular Heart Disease

Outcome Measures

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

  Baseline

Secondary Outcomes (4)

• Major Adverse Cardiovascular Event (MACE)

  Up to 5 years

• All-cause mortality

  Up to 5 years

• Cardiovascular mortality

  Up to 5 years

• Hospitalization for heart failure

  Up to 5 years

Interventions

Intervention not provided OTHER

This study is purely observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• History of prior valve surgery or percutaneous valve intervention (concerning a valve other than those involved in the definition of MMVD).
• Complex congenital heart diseases.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• European Association of Cardiovascular Imaging: collaborator

Study Sites (1)

Assistance Publique Hôpitaux de Paris

Paris, Île-de-France Region, 75010, France

RECRUITING

Related Publications (1)

• Unger A, Mandoli GE, Neglia D, Romero Dorta E, Kagiyama N, Borodzicz-Jazdzyk S, Velegraki E, Coisne A, Uygur B, Afana A, Florence J, Bohbot Y, Donal E, Clavel MA, Pibarot P, Unger P, Manka R, Nijveldt R, Gimelli A, Gerber B, Dweck M, Muraru D, Pontone G, Ajmone Marsan N, Timoteo AT, Toupin S, Pereira C, Cosyns B, Vicaut E, Delgado V, Petersen S, Pezel T. Rational and design of EACVI-MMVD study: an international registry on multimodality imaging for mixed and multiple valvular heart disease. Eur Heart J Imaging Methods Pract. 2026 Feb 2;4(1):qyaf156. doi: 10.1093/ehjimp/qyaf156. eCollection 2026 Jan.

  PMID: 41635678 DERIVED

MeSH Terms

Conditions

Heart Valve Diseases; Aortic Valve Disease; Aortic Valve Stenosis; Aortic Valve Insufficiency; Mitral Valve Stenosis; Mitral Valve Insufficiency; Tricuspid Valve Insufficiency; Tricuspid Valve Stenosis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Central Study Contacts

Théo PEZEL, MD PhD

CONTACT

668722489; theo.pezel@aphp.fr

Alexandre UNGER, MD

CONTACT

478487691; alexandre.unger@ulb.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: January 31, 2024
• Study Start: February 7, 2024
• Primary Completion: August 1, 2024
• Study Completion (Estimated): August 1, 2029
• Last Updated: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)