Comparing early and delayed aortic valve replacement for patients with moderate aortic stenosis and mitral regurgitation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the safety and efficacy of early versus deferred aortic valve replacement (AVR) in patients who have moderate aortic stenosis combined with moderate mitral regurgitation. It aims to address the lack of data on the timing of intervention for patients with multivalvular heart disease, as current guidelines primarily focus on isolated valvular lesions. The study will involve either transcatheter or surgical AVR, with the timing of intervention based on specific hemodynamic criteria. By exploring these approaches, the study seeks to determine if early intervention can provide better outcomes for patients with this complex condition.

Why it matters

Who can join: the full rules

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.

Where it's running

• Insel Gruppe AG, Inselspital Bern
  Bern, Switzerland Recruiting
• University Hospital Geneva (HUG)
  Geneva, Switzerland Recruiting
• Heart Clinic Hirslanden
  Zurich, Switzerland Recruiting

Study contacts

• Principal investigator: Thomas Pilgrim, Prof. Dr. — Insel Gruppe AG
• Study coordinator: Thomas Pilgrim, Prof. Dr.
• Email: kardio.studien@insel.ch
• Phone: 0041316325000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.