NCT06789211 Outcomes in Moderate Mixed Aortic Valve Disease
| NCT ID | NCT06789211 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Leiden University Medical Center |
| Condition | Mixed Aortic Valve Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,900 participants |
| Start Date | 2024-06-06 |
| Primary Completion | 2026-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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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 1,900 participants in total. It began in 2024-06-06 with a primary completion date of 2026-03-01.
⚠ 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
Mixed aortic valve disease (MAVD) is defined as the combination of aortic valve stenosis (AS) and regurgitation (AR) and is relatively frequent, with a reported prevalence up to 20-30% of patients with aortic valve disease. Mortality of patients with moderate MAVD (coexistence of both moderate AS and moderate AR) is largely unknown, and therefore there are currently no guidelines-based indications for surgical or transcatheter intervention for these patients, which is considered only when one of the two lesions (AS or AR) becomes severe. Of note, indication for valve intervention in patients with isolated moderate AS is currently under investigation in several randomized clinical trials but only in the presence of relevant symptoms and signs of left ventricular (LV) dysfunction. One initial single-center study including 250 patients with moderate MAVD has evaluated outcomes in this specific subgroup and showed that patients with asymptomatic moderate MAVD and preserved left ventricular ejection fraction (LVEF) had similar adverse event rates (progression to New York Heart Association (NYHA) class III-IV, aortic valve intervention or cardiac death) to patients with isolated asymptomatic severe AS with preserved LVEF. However, the results were primarily driven by the progression of the NYHA Class and aortic valve replacement, and larger multi-center studies are advocated to confirm these findings, which may therefore identify a (new) group of high risk patients who should in principle benefit from an aortic valve intervention as much as patients with isolated severe AS. In addition, prognostic factors (including clinical and echocardiographic characteristics) for risk-stratification of patients with moderate MAVD have not been identified, which may help to refine the indication for valve intervention and optimize patient management.
Eligibility Criteria
Inclusion Criteria: 1. Patients with concomitant moderate AS and moderate AR 2. Patients with isolated severe AS 3. Patients with isolated severe AR Exclusion Criteria: 1. Previous aortic valve surgery 2. Concomitant left valvular heart disease more than mild grade 3. Acute AR 4. Bad echocardiographic image quality
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06789211 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mixed Aortic Valve Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06789211 currently recruiting?
Yes, NCT06789211 is actively recruiting participants. Contact the research team at n.ajmone@lumc.nl for enrollment information.
Where is the NCT06789211 trial being conducted?
This trial is being conducted at Leiden, Netherlands.
Who is sponsoring the NCT06789211 clinical trial?
NCT06789211 is sponsored by Leiden University Medical Center. The trial plans to enroll 1,900 participants.