Status:
RECRUITING
Early Versus Deferred Aortic Valve Replacement in Patients With Moderate Aortic Stenosis and Mitral Regurgitation
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Aortic Valve Replacement in Patients With Moderate Aortic Stenosis Combined With Mitral Regurgitation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 regurgitati...
Detailed Description
In more than one-half of all patients with valvular heart disease, more than a single valve is involved. Valvular aortic stenosis coexists with significant mitral valve disease in up to one-third of p...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Moderate native aortic stenosis defined by an aortic valve area (AVA) ≤1.5 cm2 and \>1.0 cm2 and transvalvular mean gradient ≥20 mmHg and \<40 mmHg.
- Primary or secondary mitral regurgitation (at least moderate) defined by effective regurgitant orifice area (EROA) ≥20 mm2 or regurgitant volume ≥30 ml
- New York Heart Association (NYHA) functional class ≥2
Exclusion
- Life expectancy \<1 year irrespective of valvular heart disease
- Left ventricular ejection fraction \<30% or LVESD \>70mm
- Echocardiographic evidence of severe right ventricular dysfunction
- Untreated clinically significant CAD requiring revascularisation
- Moderate or severe aortic regurgitation
- Severe tricuspid valve disease requiring intervention
- Symptomatic patients with severe primary MR who are operable and not high risk
- Patients with severe secondary MR who remain symptomatic despite optimal medical therapy and who are judged appropriate for transcatheter edge-to-edge repair or surgery by the Heart Team
- Transcatheter or surgical treatment of valvular and/or coronary artery disease within 90 days prior to randomization
- COPD with home oxygen therapy
- Estimated or measured systolic PAP \>70 mmHg
- Stroke within 30 days prior to the randomization
- Inability to provide written informed consent
- Participation in another cardiovascular trial before reaching the primary endpoint.
Key Trial Info
Start Date :
August 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2030
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05310461
Start Date
August 17 2022
End Date
January 1 2030
Last Update
November 21 2023
Active Locations (3)
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1
Insel Gruppe AG, Inselspital Bern
Bern, Switzerland, 3010
2
University Hospital Geneva (HUG)
Geneva, Switzerland
3
Heart Clinic Hirslanden
Zurich, Switzerland