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Compares treatment options for Aortic Valve Replacement in Patients With Moderate Aortic...
Official title Early Versus Deferred Aortic Valve Replacement in Patients With Moderate Aortic Stenosis and Mitral Regurgitation
ClinicalTrials.gov ID: NCT05310461
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- New York Heart Association (NYHA) functional class ≥2
You likely can't join if
- Life expectancy \<1 year irrespective of valvular heart disease
- Left ventricular ejection fraction \ 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
See the full eligibility 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
- Life expectancy \<1 year irrespective of valvular heart disease
- Left ventricular ejection fraction \ 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bern, Switzerland
- Geneva, Switzerland
- Zurich, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bern, Switzerland; Geneva, Switzerland; Zurich, Switzerland. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.