Comparing early and delayed aortic valve replacement for 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
This study is testing whether getting aortic valve replacement sooner or later is better for people with moderate aortic stenosis and mitral regurgitation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 3 sites (Bern and 2 other locations) |
| Trial ID | NCT05310461 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with moderate aortic stenosis and moderate mitral regurgitation who meet specific hemodynamic criteria.
Not a fit: Patients with severe valvular heart disease or those with a life expectancy of less than one year are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with combined aortic stenosis and mitral regurgitation, potentially enhancing their quality of life and survival rates.
How similar studies have performed: While there is limited data on the timing of intervention for multivalvular disease, similar studies have shown promise in improving outcomes for patients with isolated valvular lesions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bern and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.