Danish National Randomized Study on Early Aortic Valve Replacement in Patients With Asymptomatic Severe Aortic Stenosis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorOdense University Hospital

About this trial

The purpose of this study is to examine the impact of early surgery in patients with asymptomatic severe aortic valve stenosis with signs of subclinical LV dysfunction despite preserved LVEF, with a watchfull waiting approach.

Eligibility criteria

Qualifiers

1. Severe AS defined as

aortic valve area (AVA) ≤1 cm2, AND

Transvalvular maximum velocity (Vmax) ≥3.5 m/s AND

AS severity evaluated severe by a heart valve team conference. In cases where severity is not unambiguous an integrative approach will be utilized combining echocardiographic markers of valve severity and LV function, and if necessary aortic valve calcification estimated by non-contrast CT.

Disqualifiers

LVEF<50%

Very severe AS defined as Vmax>5 m/s.

Concomitant severe valvular disease other than AS

Previous valvular surgery

Trial design

Treatments tested in this trial

  • Aortic valve replacement

Treatment groups

1,700 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Odense University Hospital

Lead sponsor

Rigshospitalet, Denmark

Collaborator

Aarhus University Hospital

Collaborator

Aalborg University Hospital

Collaborator

Zealand University Hospital

Collaborator