NCT03972644 Danish National Randomized Study on Early Aortic Valve Replacement in Patients With Asymptomatic Severe Aortic Stenosis
| NCT ID | NCT03972644 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Odense University Hospital |
| Condition | Aortic Valve Stenosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,700 participants |
| Start Date | 2020-01-01 |
| Primary Completion | 2029-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,700 participants in total. It began in 2020-01-01 with a primary completion date of 2029-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 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 <!-- --> 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03972644 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Aortic Valve Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03972644 currently recruiting?
Yes, NCT03972644 is actively recruiting participants. Contact the research team at jordi.dahl@rsyd.dk for enrollment information.
Where is the NCT03972644 trial being conducted?
This trial is being conducted at Odense, Denmark.
Who is sponsoring the NCT03972644 clinical trial?
NCT03972644 is sponsored by Odense University Hospital. The trial plans to enroll 1,700 participants.