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โ† Trials
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Early Versus Deferred Aortic Valve Replacement in Patients With Moderate Aortic Stenosis and Mitral Regurgitation

RecruitingNAAges 18 Years - anyAllInsel Gruppe AG, University Hospital Bern
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ18 years * Moderate native aortic stenosis defined by an aortic valve area (AVA) โ‰ค1.5 cm2 and \>1.0 cm2 and transvalvular mean gradient โ‰ฅ20 mmHg and \<40 mmHg. * Primary or secondary mitral regurgitation (at least moderate) defined by effective regurgitant orifice area (EROA) โ‰ฅ20 mm2 or regurgitant volume โ‰ฅ30 ml * New York Heart Association (NYHA) functional class โ‰ฅ2 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.
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What it tests

  • Transcatheter or surgical aortic valve replacement with or without transcatheter or surgical mitral valve repair/replacement
  • Deferred treatment, with intervention once AVA is โ‰ค1.0 cm2 or if concomitant mitral regurgitation meets an indication for intervention
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Where

3 sites
Insel Gruppe AG, Inselspital Bern
Bern, Switzerland
University Hospital Geneva (HUG)
Geneva, Switzerland
Heart Clinic Hirslanden
Zurich, Switzerland
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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