Clinical Trials in Denmark / NCT03972644
Recruiting
Not applicable
Danish National Randomized Study on Early Aortic Valve Replacement in Patients With Asymptomatic Severe Aortic Stenosis
NCT03972644 · tracked via the Priya Life Science Denmark tracker
Condition(s) studied
Aortic Valve StenosisDiastolic Dysfunction
Investigational drug(s) / intervention(s)
Aortic valve replacement
Aortic valve replacement: Open heart surgery or transcatheter surgery
Study summary
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
Inclusion Criteria:
* 1\. Severe AS defined as
1. aortic valve area (AVA) ≤1 cm2, AND
2. Transvalvular maximum velocity (Vmax) ≥3.5 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
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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 ≥18 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
Primary outcome measure(s)
- all-cause mortality — After 379 events (approx 5 years)
All-cause mortality assessed by Danish patient records
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Odense University Hospital | Odense | Fyn | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03972644 on ClinicalTrials.gov ↗ ← All trials in Denmark