Evaluating outcomes in patients with moderate mixed aortic valve disease

Impact of Symptoms and Left Ventricular Systolic Function in Patients With Moderate Mixed Aortic Valve Disease

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
• Enrollment: 1900 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Leiden University Medical Center (other)
• Locations: 1 site (Leiden, South Holland)
• Trial ID: NCT06789211 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include patients diagnosed with concomitant moderate AS and moderate AR, as well as those with isolated severe AS or AR.

Not a fit: Patients who have previously undergone aortic valve surgery or have significant left valvular heart disease may not benefit from this study.

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 performed: While there have been studies on isolated moderate AS, this specific investigation into moderate MAVD is relatively novel and has not been extensively tested.

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

Where this trial is running

Leiden, South Holland

• Leiden University Medical Center — Leiden, South Holland, Netherlands (RECRUITING)

Study contacts

• Study coordinator: Nina Ajmone Marsan, MD, PhD

Conditions: Mixed Aortic Valve Disease, valvular heart disease, mixed aortic valve disease