Actively Recruiting

Age: 18Years +
All Genders
NCT06789211

Outcomes in Moderate Mixed Aortic Valve Disease

Led by Leiden University Medical Center · Updated on 2025-09-15

1900

Participants Needed

1

Research Sites

129 weeks

Total Duration

On this page

Sponsors

L

Leiden University Medical Center

Lead Sponsor

E

Edwards Lifesciences

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Outcomes in Moderate Mixed Aortic Valve Disease

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with both moderate aortic valve stenosis and moderate aortic valve regurgitation
  • Patients with isolated severe aortic valve stenosis
  • Patients with isolated severe aortic valve regurgitation
Not Eligible

You will not qualify if you...

  • Previous aortic valve surgery
  • Severe left valvular heart disease beyond mild grade
  • Acute aortic valve regurgitation
  • Poor quality echocardiographic images

AI-Screening

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Trial Site Locations

Total: 1 location

1

Leiden University Medical Center

Leiden, South Holland, Netherlands, 2333ZA

Actively Recruiting

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Research Team

N

Nina Ajmone Marsan, MD, PhD

CONTACT

J

Jeroen Bax, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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