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RecruitingNot ApplicableNCT05310461

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

Sponsor

Insel Gruppe AG, University Hospital Bern

Enrollment

80 participants

Start Date

Aug 17, 2022

Study Type

INTERVENTIONAL

Conditions

Aortic Valve Replacement in Patients With Moderate Aortic Stenosis Combined With Mitral Regurgitation

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 regurgitation.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria14

  • 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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Interventions

PROCEDURETranscatheter 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.

PROCEDUREDeferred 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

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NCT05310461