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โ† Trials
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Danish National Randomized Study on Early Aortic Valve Replacement in Patients With Asymptomatic Severe Aortic Stenosis

RecruitingNAAges 18 Years - 85 YearsAllOdense University Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 1\. Severe AS defined as 1. aortic valve area (AVA) โ‰ค1 cm2, AND 2. Transvalvular maximum velocity (Vmax) โ‰ฅ3.5 m/s AND 3. 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. 2\. Considered to be asymptomatic (estimated by a consultant in cardiology) 3. Considered to be candidate for AVR (transcatheter AVR/surgical AVR) 4. Sign of increased LV filling pressures18 or reduced longitudinal LV systolic function <!-- --> 1. Left atrial volume index (LAVi) \> 34 ml/m2; OR 2. ratio of early diastolic peak mitral inflow velocity (E) to early mitral annulus diastolic velocity (e') ratio E/e'avg\>13; OR 3. Threefold elevation in NT-proBNP compared to the upper expected age and gender value. OR 4. GLS\>-15 5. Age โ‰ฅ18 years 6. Signed informed consent Exclusion Criteria: 1. LVEF\<50% 2. Very severe AS defined as Vmax\>5 m/s. 3. Concomitant severe valvular disease other than AS 4. Previous valvular surgery 5. Estimated glomerular filtration rate\<30 ml/min/m2 6. Dementia 7. Women of childbearing potential 8. Inability to provide informed consent 9. Age\>85 years. 10. Supravalvular or subvalvular AS
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What it tests

  • Aortic valve replacement
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Where

1 site
Odense University Hospital
Odense, Denmark
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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