Outcomes in Moderate Mixed Aortic Valve Disease

NCT ID: NCT06789211

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1900 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-06
• Study Completion Date: 2026-12-01

Brief Summary

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.

Detailed Description

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:

1. 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.

2. 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.

Conditions

Mixed Aortic Valve Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Moderate Mixed Aortic Valve Disease

No interventions assigned to this group

Severe Aortic Stenosis

No interventions assigned to this group

Severe Aortic Regurgitation

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Edwards Lifesciences

INDUSTRY

Sponsor Role: collaborator

Queen Mary Hospital, Hong Kong

OTHER

Sponsor Role: collaborator

National Heart Centre Singapore

OTHER

Sponsor Role: collaborator

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

OTHER

Sponsor Role: collaborator

Leiden University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Nina Ajmone Marsan

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Leiden University Medical Center

Leiden, South Holland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Nina Ajmone Marsan, MD, PhD

Role: CONTACT

n.ajmone@lumc.nl

31715262020

Jeroen Bax, MD, PhD

Role: CONTACT

j.j.bax@lumc.nl

31 (0)71 526 2020

Facility Contacts

Nina Ajmone Marsan, MD, PhD

Role: primary

n.ajmone@lumc.nl

31071262020

Other Identifiers

THV-I24-181

Identifier Type: OTHER

Identifier Source: secondary_id

DAP/tak/1662024

Identifier Type: -

Identifier Source: org_study_id