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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

‣ 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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‣ 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

Locations
Other Locations
Denmark
Odense University Hospital
RECRUITING
Odense
Contact Information
Primary
Jordi S Dahl, MD, PhD
jordi.dahl@rsyd.dk
+4523823016
Backup
Jacob E Møller, MD, PhD
jem@dadlnet.dk
Time Frame
Start Date: 2020-01-01
Estimated Completion Date: 2029-09-01
Participants
Target number of participants: 1700
Treatments
Active_comparator: Early intervention
Patients will undergo aortic valve replacement immediately
No_intervention: Watchfull waiting
Patients will be followed and treated as recommended by guidelines.
Sponsors
Leads: Odense University Hospital
Collaborators: Zealand University Hospital, Aalborg University Hospital, Aarhus University Hospital, Rigshospitalet, Denmark

This content was sourced from clinicaltrials.gov