Danish National Randomized Study on Early Aortic Valve Replacement in Patients With Asymptomatic Severe Aortic Stenosis
Key facts
- Where
- Odense, DenmarkSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT03972644, who can take part
Where in Denmark
- Odense University HospitalOdense, DenmarkContact: Jordi S Dahl, MD, Ph.DTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Odense University Hospital
- Trial code
- NCT03972644
- Record updated
- 14 September 2020
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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; 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; <!-- -->; Left atrial volume index (LAVi) > 34 ml/m2; OR; ratio of early diastolic peak mitral inflow velocity (E) to early mitral annulus diastolic velocity (e') ratio E/e'avg>13; OR; Threefold elevation in NT-proBNP compared to the upper expected age and gender value. OR; GLS>-15 5. Age ≥18 years 6. Signed informed consent.
Exclusion: Concomitant severe valvular disease other than AS; Previous valvular surgery; Dementia; LVEF<50%; Age>85 years; Very severe AS defined as Vmax>5 m/s; Estimated glomerular filtration rate<30 ml/min/m2; Women of childbearing potential; Inability to provide informed consent; Supravalvular or subvalvular AS.