Actively Recruiting
Danish National Randomized Study on Early Aortic Valve Replacement in Patients With Asymptomatic Severe Aortic Stenosis
Led by Odense University Hospital · Updated on 2020-09-14
1700
Participants Needed
1
Research Sites
504 weeks
Total Duration
On this page
Sponsors
O
Odense University Hospital
Lead Sponsor
R
Rigshospitalet, Denmark
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Danish National Randomized Study on Early Aortic Valve Replacement in Patients With Asymptomatic Severe Aortic Stenosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Severe aortic stenosis defined by aortic valve area 60; 1 cm2 and maximum velocity 60; 3.5 m/s and evaluated as severe by a heart valve team
- Considered asymptomatic by a cardiology consultant
- Candidate for aortic valve replacement (transcatheter or surgical)
- Signs of increased left ventricular filling pressures or reduced longitudinal LV systolic function, including left atrial volume index > 34 ml/m2, E/e' ratio > 13, threefold elevation in NT-proBNP, or GLS > -15
- Age 18 years or older
- Signed informed consent
You will not qualify if you...
- Left ventricular ejection fraction below 50%
- Very severe aortic stenosis with maximum velocity above 5 m/s
- Severe valvular disease other than aortic stenosis
- Previous valvular surgery
- Estimated glomerular filtration rate below 30 ml/min/m2
- Dementia
- Women of childbearing potential
- Inability to provide informed consent
- Age over 85 years
- Supravalvular or subvalvular aortic stenosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Odense University Hospital
Odense, Fyn, Denmark, 5000
Actively Recruiting
Research Team
J
Jordi S Dahl, MD, PhD
CONTACT
J
Jacob E Møller, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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