Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:43 PM
Ignite Modification Date:
2025-12-24 @ 12:43 PM
NCT ID:
NCT05310461
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05310461
Study Brief:
Protocol Section:
NCT05310461