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New treatment option for Aortic Valve Stenosis
Official title Danish National Randomized Study on Early Aortic Valve Replacement in Patients With Asymptomatic Severe Aortic Stenosis
ClinicalTrials.gov ID: NCT03972644
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 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...
- Left atrial volume index (LAVi) \> 34 ml/m2; OR
You likely can't join if
- 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
See the full eligibility criteria
- 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Odense, Fyn, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Odense, Fyn, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.