NCT06235385 European Association of Cardiovascular Imaging Multiple and Mixed Valvular Disease Study
| NCT ID | NCT06235385 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Heart Valve Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,500 participants |
| Start Date | 2024-02-07 |
| Primary Completion | 2024-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,500 participants in total. It began in 2024-02-07 with a primary completion date of 2024-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06235385 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Valve Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06235385 currently recruiting?
Yes, NCT06235385 is actively recruiting participants. Contact the research team at theo.pezel@aphp.fr for enrollment information.
Where is the NCT06235385 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06235385 clinical trial?
NCT06235385 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 1,500 participants.