Evaluating outcomes in patients with moderate mixed aortic valve disease
Official title: Impact of Symptoms and Left Ventricular Systolic Function in Patients With Moderate Mixed Aortic Valve Disease
Run by Leiden University Medical Center · NCT06789211 · Data updated 2026-11-12
This study is trying to see if patients with moderate mixed aortic valve disease have different death rates compared to those with severe aortic stenosis or regurgitation, and if they might benefit from treatment even if they don’t have severe symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1900 (estimated) |
| Sponsor | Leiden University Medical Center Academic / other |
| Locations | 1 site (Leiden, South Holland) |
| Status | Recruiting |
| Started | June 6, 2024 |
| Main results expected | March 1, 2026 |
| Study ends | December 1, 2026 |
| Registry record updated | September 15, 2025 |
| Trial ID | NCT06789211 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients diagnosed with concomitant moderate AS and moderate AR, as well as those with isolated severe AS or AR.
✕Probably not a fit
Patients who have previously undergone aortic valve surgery or have significant left valvular heart disease 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 assess the mortality rates of patients with moderate mixed aortic valve disease (MAVD) compared to those with isolated severe aortic stenosis (AS) and isolated severe aortic regurgitation (AR). The study will analyze clinical and echocardiographic characteristics to identify factors associated with increased mortality in this population. By examining a multi-center cohort, the research seeks to establish whether patients with moderate MAVD may benefit from aortic valve intervention, even in the absence of severe symptoms or left ventricular dysfunction.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment guidelines for patients with moderate MAVD, potentially reducing mortality rates.
How similar studies have gone: While there have been studies on isolated moderate AS, this specific investigation into moderate MAVD is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Leiden University Medical Center
Leiden, South Holland, Netherlands Recruiting
Study contacts
- Study coordinator: Nina Ajmone Marsan, MD, PhD
- Email: n.ajmone@lumc.nl
- Phone: 31715262020
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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.