RECRUITINGINTERVENTIONAL
Early Versus Deferred Aortic Valve Replacement in Patients With Moderate Aortic Stenosis and Mitral Regurgitation
Early Versus Deferred Aortic Valve Replacement in Patients With Moderate Aortic Stenosis Combined With Mitral Regurgitation: a Randomized Clinical Trial
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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 willing to sign a consent form
- Participation in another cardiovascular trial before reaching the primary endpoint.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* 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 Criteria:
* 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.
Treatments Being Tested
PROCEDURE
Transcatheter or surgical aortic valve replacement with or without transcatheter or surgical mitral valve repair/replacement
Early transcatheter or surgical aortic valve replacement with or without transcatheter or surgical mitral valve repair/replacement.
PROCEDURE
Deferred treatment, with intervention once AVA is ≤1.0 cm2 or if concomitant mitral regurgitation meets an indication for intervention
Deferred transcatheter or surgical aortic valve replacement with or without transcatheter or surgical mitral valve repair/replacement.
Locations (3)
Insel Gruppe AG, Inselspital Bern
Bern, Switzerland
University Hospital Geneva (HUG)
Geneva, Switzerland
Heart Clinic Hirslanden
Zurich, Switzerland