Early Versus Deferred Aortic Valve Replacement in Patients With Moderate Aortic Stenosis and Mitral Regurgitation

Launched by INSEL GRUPPE AG, UNIVERSITY HOSPITAL BERN · Mar 25, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the best timing for a surgery called aortic valve replacement in patients who have moderate aortic stenosis (a narrowing of the heart's aortic valve) and moderate mitral regurgitation (leaking of the heart's mitral valve). The trial compares two approaches: doing the surgery early versus waiting until the patient shows more severe symptoms. Researchers want to find out which approach is safer and more effective for patients.

To participate in this trial, you need to be at least 18 years old and have been diagnosed with moderate aortic stenosis and moderate mitral regurgitation. You should also be experiencing some heart-related symptoms, as defined by a specific classification. However, if you have certain serious heart conditions or other health issues that could complicate your treatment, you may not be eligible. If you join the trial, you will be closely monitored throughout the process to assess your health and the effects of the surgery. This study is important because it aims to improve treatment decisions for patients with these heart conditions.

Gender

ALL

Eligibility criteria

• 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.