Early Aortic Valve Replacement for Patients With Asymptomatic Severe Aortic Stenosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of early aortic valve replacement (AVR) in patients who have asymptomatic severe aortic stenosis but show signs of subclinical left ventricular dysfunction. The research aims to determine whether performing surgery before the onset of symptoms can improve long-term outcomes compared to a watchful waiting approach. The study will evaluate patients based on specific echocardiographic markers and other indicators of left ventricular filling pressures. The goal is to provide insights into the timing of surgical intervention in this patient population.

Why it matters

Who can join: the full rules

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

Where it's running

• Odense University Hospital
  Odense, Fyn, Denmark Recruiting

Study contacts

• Study coordinator: Jordi S Dahl, MD, PhD
• Email: jordi.dahl@rsyd.dk
• Phone: +4523823016

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Transcatheter Aortic Valve Replacement Registry for Outcomes and Quality Monitoring

  This registry collects information from hospitals about patients undergoing TAVR to see how care and outcomes compare to guidelines and nationwide data.

  Recruiting American College of Cardiology · Washington D.C., District of Columbia · NCT07908355

• Vericiguat to slow calcific aortic valve narrowing

  This trial tests whether vericiguat can slow the progression of mild-to-moderate calcific aortic valve stenosis compared with placebo.

  Recruiting Phase 2 West China Hospital · Chengdu, Sichuan · NCT07715279

• CHATEAU Registry: Real-world outcomes after TAVR

  This registry collects real-world data from adults who had TAVR between 2021 and 2025 to see how they do over time and how valve performance holds up.

  Recruiting Eunpyeong St. Mary's Hospital · Seoul · NCT07709858

• Impact of TAVR on kidney function in people with aortic valve disease

  This registry tests how trans-catheter aortic valve implantation affects kidney function and the risk of kidney injury in adults with aortic stenosis.

  Recruiting Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Roma, RM · NCT07626710

• Hydra THV Transfemoral Valve Implantation in Severe Aortic Stenosis

  This registry tests how safely and effectively the Hydra THV works when implanted through the femoral artery in adults with severe symptomatic aortic stenosis.

  Recruiting at 8 sites Fundación EPIC · Aravaca and 7 other locations · NCT07566624

• How the type of sedation affects recovery after TAVR

  This study will test whether three common sedation approaches (propofol, dexmedetomidine, or midazolam with fentanyl) change how people recover on the first day after transfemoral TAVR.

  Recruiting Phase 4 Endeavor Health · Glenview, Illinois · NCT07556523

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.