Investigating multiple and mixed heart valve diseases
European Association of Cardiovascular Imaging Multiple and Mixed Valvular Disease Study
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 |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris, Île-de-France Region) |
| Trial ID | NCT06235385 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of MMVD who are referred to a cardiovascular imaging department.
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.
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 performed: While the approach is observational and builds on existing knowledge, the specific focus on MMVD in a large multicenter setting is relatively novel.
Eligibility criteria
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 this trial is running
Paris, Île-de-France Region
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.