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.
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.
LVEF<50%
Very severe AS defined as Vmax>5 m/s.
Concomitant severe valvular disease other than AS
Previous valvular surgery
Parallel
Aortic valve replacement
Procedure/SurgeryOpen heart surgery or transcatheter surgery
all-cause mortality
All-cause mortality assessed by Danish patient records
Combined endpoint
All-cause mortality + hospitalization due to heart failure and stroke
all-cause mortality in patients with low-gradient AS
All-cause mortality in patients with meangradient \<40 mmHg
Combined endpoint in low-gradient AS
All-cause mortality + hospitalization to heart failure and stroke when MG\<40 mmHg
Pericardiocentesis
Need of pericariocentesis
sternal infection
hospitalization due to sternal infection
Persistent renal failure
complete loss of renal function exceeding 4 weeks.
endocarditis
hospitalization due to endocarditis
Click on the lead sponsor to view all of their trials.
Odense University Hospital
Lead sponsor
Rigshospitalet, Denmark
Collaborator
Aarhus University Hospital
Collaborator
Aalborg University Hospital
Collaborator
Zealand University Hospital
Collaborator
