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NCT Number: NCT06789211

Outcomes in Moderate Mixed Aortic Valve Disease

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Leiden University Medical Center

Leiden, South Holland, 2333ZA, Netherlands

Location status: Recruiting

Location contact

Nina Ajmone Marsan, MD, PhD

CONTACT

[email protected]

31071262020

Nina Ajmone Marsan, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

Hypothesis: Patients with moderate MAVD may have similar mortality rates compared to patients with isolated severe AS or severe AR and therefore benefit from aortic valve intervention. The presence of symptoms or impaired LV function may further identify a higher risk group together with other clinical or echocardiographic parameters.

Objectives:

  • To compare mortality rates in patients with moderate MAVD to isolated severe AS and isolated severe AR in a multi-center setting, adjusting for potential differences in clinical and echocardiographic variables and for the occurrence of aortic valve intervention.
  • To identify clinical and echocardiographic characteristics associated with increased mortality in this specific population and potentially propose dedicated risk scoring and adjusted cut-off values for the various parameters.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with concomitant moderate AS and moderate AR
  • Patients with isolated severe AS
  • Patients with isolated severe AR

Exclusion criteria

  • Previous aortic valve surgery
  • Concomitant left valvular heart disease more than mild grade
  • Acute AR
  • Bad echocardiographic image quality

Treatment and study plan

Primary outcomes

  1. All-cause mortality

    Time frame: 2003-2024

Secondary outcomes

  1. All-cause mortality or aortic valve replacement

    Time frame: 2003-2024

Study contacts

Contact information is provided by the study sponsor or research team.

Jeroen Bax, MD, PhD

CONTACT

[email protected]

31 (0)71 526 2020

Nina Ajmone Marsan, MD, PhD

CONTACT

[email protected]

31715262020

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Collaborators

  • Edwards Lifesciences
  • Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
  • National Heart Centre Singapore
  • Queen Mary Hospital, Hong Kong

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2025
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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