ClinicalTrialsFinder
RecruitingNot ApplicableNCT03972644

Danish National Randomized Study on Early Aortic Valve Replacement in Patients With Asymptomatic Severe Aortic Stenosis

Sponsor

Odense University Hospital

Enrollment

1,700 participants

Start Date

Jan 1, 2020

Study Type

INTERVENTIONAL

Conditions

Diastolic DysfunctionAortic Valve Stenosis

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

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria10

  • \. 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 Criteria10

  • LVEF<50%
  • Very severe AS defined as Vmax>5 m/s.
  • Concomitant severe valvular disease other than AS
  • Previous valvular surgery
  • Estimated glomerular filtration rate<30 ml/min/m2
  • Dementia
  • Women of childbearing potential
  • Inability to provide informed consent
  • Age>85 years.
  • Supravalvular or subvalvular AS

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREAortic valve replacement

Open heart surgery or transcatheter surgery

Locations(1)

Odense University Hospital

Odense, Fyn, Denmark

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03972644

Related Trials

Patient Quality of Recovery After TAVR With Different Sedation Regimens

NCT075565231 location

Hydra Single-centre Experience - Copenhagen, Denmark

NCT063426351 location

Hydra Registry - UK

NCT065075794 locations

Hydra Registry - Italy Experience

NCT059566524 locations

COronary Re-engageMent aFter randOm NavitoR alignmenT (COMFORT STUDY)

NCT057797871 location