Actively Recruiting
Early Versus Deferred Aortic Valve Replacement in Patients With Moderate Aortic Stenosis and Mitral Regurgitation
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2023-11-21
80
Participants Needed
3
Research Sites
384 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The aim of the present study is to investigate safety and efficacy of early versus deferred aortic valve replacement in patients with moderate aortic stenosis combined with moderate mitral regurgitation.
CONDITIONS
Official Title
Early Versus Deferred Aortic Valve Replacement in Patients With Moderate Aortic Stenosis and Mitral Regurgitation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Moderate native aortic stenosis with an aortic valve area between 1.0 and 1.5 cm2 and a transvalvular mean gradient between 20 mmHg and 40 mmHg
- Primary or secondary mitral regurgitation that is at least moderate, defined by an effective regurgitant orifice area of 20 mm2 or more or a regurgitant volume of 30 ml or more
- New York Heart Association (NYHA) functional class 2 or higher
You will not qualify if you...
- Life expectancy less than 1 year regardless of valvular heart disease
- Left ventricular ejection fraction below 30% or left ventricular end-systolic diameter over 70 mm
- Severe right ventricular dysfunction shown by echocardiography
- Untreated clinically significant coronary artery disease requiring revascularization
- Moderate or severe aortic regurgitation
- Severe tricuspid valve disease needing intervention
- Symptomatic patients with severe primary mitral regurgitation who are operable and not high risk
- Patients with severe secondary mitral regurgitation who remain symptomatic despite optimal medical therapy and are eligible for transcatheter edge-to-edge repair or surgery
- Transcatheter or surgical treatment of valvular or coronary artery disease within 90 days before randomization
- Chronic obstructive pulmonary disease requiring home oxygen therapy
- Estimated or measured systolic pulmonary artery pressure over 70 mmHg
- Stroke within 30 days prior to randomization
- Inability to provide written informed consent
- Participation in another cardiovascular trial before reaching the primary endpoint
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Insel Gruppe AG, Inselspital Bern
Bern, Switzerland, 3010
Actively Recruiting
2
University Hospital Geneva (HUG)
Geneva, Switzerland
Actively Recruiting
3
Heart Clinic Hirslanden
Zurich, Switzerland
Actively Recruiting
Research Team
T
Thomas Pilgrim, Prof. Dr.
CONTACT
B
Bartowiak Joanna, Dr. med.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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