Danish National Randomized Study on Early Aortic Valve Replacement in Patients With Asymptomatic Severe Aortic Stenosis
Recruiting
N/A
Interventional Study
Aortic Valve Stenosis
Diastolic Dysfunction
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 85
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 1,700 (estimated)
- Sponsor
- Odense University Hospital · Other
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About This Trial
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.
Trial Locations
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Eligibility Criteria
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 co…
Contacts