Leiden University Medical Center
Leiden, South Holland, 2333ZA, Netherlands
Location status: Recruiting
Location contact
Nina Ajmone Marsan, MD, PhD
CONTACT
Nina Ajmone Marsan, MD, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06789211
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Leiden, South Holland, 2333ZA, Netherlands
Location status: Recruiting
Nina Ajmone Marsan, MD, PhD
CONTACT
Nina Ajmone Marsan, MD, PhD
PRINCIPAL_INVESTIGATOR
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 2003-2024
Time frame: 2003-2024
Contact information is provided by the study sponsor or research team.
Jeroen Bax, MD, PhD
CONTACT
Nina Ajmone Marsan, MD, PhD
CONTACT
Leiden University Medical Center
Other
Impact of Symptoms and Left Ventricular Systolic Function in Patients With Moderate Mixed Aortic Valve Disease
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