Early Versus Deferred Aortic Valve Replacement in Patients With Moderate Aortic Stenosis and Mitr… (NCT05310461) | Clinical Trial Compass
RecruitingNot Applicable
Early Versus Deferred Aortic Valve Replacement in Patients With Moderate Aortic Stenosis and Mitral Regurgitation
Switzerland80 participantsStarted 2022-08-17
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing early aortic valve replacement against waiting — given my specific combination of moderate aortic stenosis and mitral regurgitation, does my doctor think acting sooner or watching and waiting is currently the safer path for me?
2The trial tracks death, stroke, and unplanned heart failure hospitalizations over 2 years — based on where my disease stands right now, how does my doctor assess my personal risk for those outcomes if I delay surgery versus proceeding sooner?
3Since this is listed as Phase NA and is still actively recruiting, what does my doctor think about the current state of evidence for operating on moderate aortic stenosis — is there enough known about risks and benefits to feel confident, or is this trial specifically trying to answer questions that aren't yet settled?
4This trial involves aortic valve replacement, but I also have mitral regurgitation — would the trial address both valve problems, or only the aortic stenosis, and how does my doctor think the mitral regurgitation should factor into any treatment decision?
5If I don't join this trial, what would the standard treatment approach look like for my combination of moderate aortic stenosis and mitral regurgitation, and is there a reason my doctor might recommend that path instead?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The primary outcome will be a composite of all-cause death, stroke, and unplanned hospitalization for heart failure related to valvular heart disease at 2 years.