Clinical trial Recruiting at 1 site Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment1900 (estimated)
SponsorLeiden University Medical Center
Academic / other
Locations1 site (Leiden, South Holland)
StatusRecruiting
StartedJune 6, 2024
Main results expectedMarch 1, 2026
Study endsDecember 1, 2026
Registry record updatedSeptember 15, 2025
Trial IDNCT06789211 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.