Investigating multiple and mixed heart valve diseases
Official title: European Association of Cardiovascular Imaging Multiple and Mixed Valvular Disease Study
Run by Assistance Publique - Hôpitaux de Paris · NCT06235385 · Data updated 2026-11-12
This study looks at how common different types of heart valve diseases are and their features by gathering information from patients around the world who have been diagnosed with these conditions.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1500 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris, Île-de-France Region) |
| Status | Recruiting |
| Started | February 7, 2024 |
| Main results expected | August 1, 2024 |
| Study ends | August 1, 2029 |
| Registry record updated | June 3, 2024 |
| Trial ID | NCT06235385 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with a confirmed diagnosis of MMVD who are referred to a cardiovascular imaging department.
✕Probably not a fit
Patients with a history of prior valve surgery, acute infective endocarditis, or complex congenital heart diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to explore the prevalence and characteristics of multiple and mixed valvular heart disease (MMVD) through a multicenter approach involving 174 centers across 35 countries. Patients diagnosed with MMVD via echocardiography will be recruited over a six-month period, with a one-year follow-up to assess clinical outcomes and management strategies. The study will evaluate various clinical, biological, and imaging characteristics, aiming to fill significant knowledge gaps regarding MMVD diagnosis and prognosis.
Why it matters
Potential benefit: If successful, this study could enhance the understanding and management of multiple and mixed valvular heart diseases, leading to improved patient outcomes.
How similar studies have gone: While the approach is observational and builds on existing knowledge, the specific focus on MMVD in a large multicenter setting is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Assistance Publique Hôpitaux de Paris
Paris, Île-de-France Region, France Recruiting
Study contacts
- Study coordinator: Théo PEZEL, MD PhD
- Email: theo.pezel@aphp.fr
- Phone: 668722489
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.