Outcomes in Moderate Mixed Aortic Valve Disease

NCT06789211 | Recruiting

• 2 other identifiers: DAP/tak/1662024THV-I24-181
• Study Type: observational
• Target: 1,900
• Locations: 1 country
• Sites: 1

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.

Conditions

Mixed Aortic Valve Disease

Keywords

valvular heart disease; mixed aortic valve disease

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  2003-2024

Secondary Outcomes (1)

• All-cause mortality or aortic valve replacement

  2003-2024

Study Arms (3)

Moderate Mixed Aortic Valve Disease

Severe Aortic Stenosis

Severe Aortic Regurgitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with concomitant moderate AS and moderate AR, patients with isolated severe AS and isolated severe AR.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Leiden University Medical Center: lead
• Edwards Lifesciences: collaborator
• Queen Mary Hospital, Hong Kong: collaborator
• National Heart Centre Singapore: collaborator
• Institut universitaire de cardiologie et de pneumologie de Québec, University Laval: collaborator

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, 2333ZA, Netherlands

RECRUITING

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Nina Ajmone Marsan, MD, PhD

CONTACT

31715262020; n.ajmone@lumc.nl

Jeroen Bax, MD, PhD

CONTACT

31 (0)71 526 2020; j.j.bax@lumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 23, 2025
• Study Start: June 6, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)