[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aortic-stenosis-calcific\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aortic-stenosis-calcific":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100612639","phase-3-pcsk9-inhibitors-in-the-treatment-of-calcific-aortic-stenosis-100612639",false,"NCT07256197","PCSK9 Inhibitors in the Treatment of Calcific Aortic Stenosis","Effect and Safety of PCSK9 Inhibitors on the Progression of Mild\u002FMiddle Calcific Aortic Stenosis: A Randomized Controlled Clinical Trial","PICASO","Inclusion Criteria:\n\n1. Aged 18-85 years old, clinically diagnosed with mild or moderate CAVS (echocardiography shows ejection fraction \\> 50%; valve orifice area \\> 1.0 cm²; left ventricular stroke volume index \\> 35 ml\u002Fm²; flow velocity ≥ 2 m\u002Fs and \\\u003C 4 m\u002Fs, or mean transvalvular pressure gradient \\\u003C 40 mmHg) and currently not requiring valve replacement therapy;\n2. LDL-C ≥ 2.6 and \\\u003C 4.9 mmol\u002FL, or Lp(a) ≥ 30 mg\u002FdL, or receiving statin therapy due to a clinical diagnosis of hypercholesterolemia\u002Fhyperlipidemia;\n3. Patients who can understand the purpose of the trial, voluntarily participate, sign the informed consent form, and are willing to undergo clinical follow-up in accordance with the trial requirements.\n\n   * The position and method of measurement have been further clarified in ultrasonic measurement to ensure comparability among all enrolled patients, as follows: Aortic valve peak flow velocity, aortic valve mean pressure gradient, and valve orifice area (select images of at least 3 consecutive cardiac cycles with stable heart rate; for atrial fibrillation, select images of more than 5 consecutive cardiac cycles; obtain the peak blood flow velocity of the aortic valve orifice using continuous wave Doppler in the apical 5-chamber view; calculate the instantaneous aortic valve pressure gradient using the simplified Bernoulli equation, and calculate the standardized aortic valve orifice area using the continuity equation; all participating sonographers will receive unified training, perform measurements in fixed views and retain images, which will then be reviewed by two experienced sonographers who are blinded to the trial in the core laboratory).\n\nExclusion Criteria:\n\n1. Any previous treatment with PCSK9 inhibitors;\n2. Patients must be treated with PCSK9 inhibitors by physician's judgment;\n3. Patients who cannot maintain PCSK9 inhibitor use for 24 months;\n4. Contraindications or hypersensitivity to PCSK9 inhibitors;\n5. Suspected or confirmed familial hypercholesterolemia;\n6. Fasting triglycerides (TG) \\>400 mg\u002FdL (4.5 mmol\u002FL) at baseline screening;\n7. Thyroid hypofunction;\n8. Active or chronic liver disease;\n9. Severe renal insufficiency (eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m²);\n10. History of intracranial hemorrhage;\n11. History of alcohol or drug abuse；\n12. Known active infection, or severe hematologic, metabolic, or endocrine dysfunction;\n13. Systemic corticosteroid or cyclosporine therapy within the past 3 months;\n14. Active malignancy;\n15. Any life-threatening condition with life expectancy less than 12 months;\n16. Rheumatic aortic stenosis;\n17. Severe mitral stenosis (mitral valve area \\\u003C1 cm²);\n18. Severe mitral or aortic regurgitation;\n19. Planned cardiac valve surgery;\n20. Left ventricular ejection fraction \\\u003C 30% or severe heart failure (NYHA class III or IV);\n21. Implanted permanent pacemaker or cardioverter-defibrillator;\n22. Drug-refractory arrhythmias;\n23. Pregnancy, lactation, or planned pregnancy.","ALL","18 Years","85 Years",{"count":21,"type":22},160,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","Calcific aortic stenosis (CAS) can cause severe adverse cardiac events, but there are currently no effective drugs that can prevent or delay the progression of the disease. Our trial aims to investigate the effect of PCSK9 inhibitors on preventing or delaying the progression of CAS.",[28],"Aortic Stenosis, Calcific",[30,31],"PCSK9 Inhibitors","Calcific Aortic Stenosis","NOT_YET_RECRUITING","2026-03-29",{"date":35,"type":36},"2026-04-02","ACTUAL",{"date":38,"type":22},"2026-04-01",{"date":40,"type":22},"2029-01-31",{"name":42,"class":43},"Beijing Anzhen Hospital","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":80},"100430806","progress-management-of-moderate-aortic-stenosis-by-clinical-surveillance-or-tavr-100430806","NCT04889872","PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR","The PROGRESS Trial: A Prospective, Randomized, Controlled Trial to Assess the Management of Moderate Aortic Stenosis by Clinical Surveillance or Transcatheter Aortic Valve Replacement","PROGRESS","Key Inclusion Criteria:\n\n1. 65 years of age or older at time of randomization\n2. Moderate aortic stenosis\n3. Subject has symptoms or evidence of cardiac damage\u002Fdysfunction\n4. The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.\n\nKey Exclusion Criteria:\n\n1. Native aortic annulus size unsuitable for the THV\n2. Anatomical characteristics that would preclude safe transfemoral placement of the introducer sheath or safe passage of the delivery system\n3. Aortic valve is unicuspid or non-calcified\n4. Bicuspid aortic valve with an aneurysmal ascending aorta \\> 4.5 cm or severe raphe\u002Fleaflet calcification\n5. Pre-existing mechanical or bioprosthetic aortic valve\n6. Severe aortic regurgitation\n7. Prior balloon aortic valvuloplasty to treat severe AS\n8. LVEF \\\u003C 20%\n9. Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak post-TAVR\n10. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation\n11. Coronary or aortic valve anatomy that increases the risk of coronary artery obstruction post-TAVR","65 Years",{"count":55,"type":22},2250,[57],"NA","This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3 \u002F SAPIEN 3 Ultra \u002F SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve systems in subjects with moderate, calcific aortic stenosis.\n\nFollowing completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.",[28,60],"Aortic Valve Stenosis",[62,63,64,65,66,67,68],"Transcatheter aortic valve replacement (TAVR)","SAPIEN 3","SAPIEN 3 Ultra","SAPIEN 3 Ultra RESILIA","Moderate aortic stenosis","Aortic stenosis","Transcatheter heart valve","RECRUITING","2025-12-12",{"date":72,"type":36},"2025-12-17",{"date":74,"type":36},"2021-10-12",{"date":76,"type":22},"2037-06",{"name":78,"class":79},"Edwards Lifesciences","INDUSTRY",80]