[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633871":3},{"organization":4,"outcomesModule":7,"designInfo":88,"detailedDescription":94,"studyPopulation":42,"armGroups":95,"interventions":104,"overallOfficials":42,"centralContacts":110,"locations":42,"responsibleParty":116,"collaborators":42,"id":118,"slug":42,"hasResults":119,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":42,"eligibilityCriteria":123,"healthyVolunteers":119,"sex":124,"minAge":125,"maxAge":42,"enrollmentInfo":126,"targetDuration":42,"studyType":129,"phases":130,"briefSummary":132,"conditions":133,"keywords":135,"overallStatus":148,"whyStopped":42,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":42},{"fullName":5,"class":6},"Meril Life Sciences Pvt. Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":42},[9],{"measure":10,"description":11,"timeFrame":12},"Primary Efficacy Endpoint","It is the composite of following:\n\nAll-cause mortality,\n\nDisabling stroke,\n\nAortic valve replacement due to advanced valve syndrome (AVS),\n\nHeart failure hospitalization,\n\nDeterioration in quality of life by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 2 years or at the time of conversion to AVR in the GDMT arm.","2-year",[14,18,21,24,27,30,33,36,40,44,47,50,53,56,60,62,64,67,71,74,77,79,83,86],{"measure":15,"description":16,"timeFrame":17},"All-cause mortality","As per VARC-3 defined criteria","Predischarge, 30-day, 6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year, 4- year, 5-year, 6-year, 7-year and 10-year",{"measure":19,"description":16,"timeFrame":20},"All stroke","Pre-discharge, 30- day, 6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year and 5-year",{"measure":22,"description":16,"timeFrame":23},"Acute Kidney Injury (AKI)","Pre-discharge, 30-day",{"measure":25,"description":16,"timeFrame":26},"Bleeding (Type 2, 3 and 4)","Predischarge, 30-day",{"measure":28,"description":16,"timeFrame":29},"Major vascular complications","30-day",{"measure":31,"description":16,"timeFrame":32},"Conduction disturbances and arrhythmias","Pre-discharge, 30-day, 6-month, 1-year, 1.5-year, 2-year, 2.5- year, 3-year and 5-year",{"measure":34,"description":16,"timeFrame":35},"New Permanent Pacemaker Implantation (PPI)","Pre-discharge, 30-day, 6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year and 5-year",{"measure":37,"description":38,"timeFrame":39},"Proportion of participants requiring initiation of Cardiac Resynchronization Therapy","Initiation of CRT (Cardiac Resynchronization Therapy Pacemaker or Defibrillator with Cardiac Resynchronization Therapy) as clinically indicated by the treating cardiologist.","Pre-discharge, 30-day, 6- month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year and 5-year",{"measure":41,"description":42,"timeFrame":43},"Aortic valve replacement due to advanced valve syndrome",null,"6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year and 5-year",{"measure":45,"description":16,"timeFrame":46},"Myocardial Infarction","Predischarge, 30-day, 6-month, 1-year, 1.5-year, 2-year",{"measure":48,"description":42,"timeFrame":49},"New York Heart Association (NYHA) functional classification","Screening, Pre-discharge, 30-day, 6-month, 1-year, 1.5-year, 2- year, 2.5-year, 3-year and 5-year",{"measure":51,"description":42,"timeFrame":52},"Six-minute walk test","Screening, 30-day, 6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year and 5-year",{"measure":54,"description":42,"timeFrame":55},"Echocardiographic endpoints","Screening, Pre-discharge, 30-day, 6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year, 5-year and 10- year",{"measure":57,"description":58,"timeFrame":59},"Bioprosthetic valve failure","VARC-3 defined criteria","1-year, 1.5-year, 2-year, 2.5-year, 3-year, 5-year and 10-year",{"measure":61,"description":58,"timeFrame":59},"Bioprosthetic valve deterioration",{"measure":63,"description":16,"timeFrame":59},"Aortic bioprosthetic valve dysfunction",{"measure":65,"description":16,"timeFrame":66},"Heart failure hospitalization","30-day, 6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year and 5-year",{"measure":68,"description":69,"timeFrame":70},"Kansas City Cardiomyopathy Questionnaire","Overall Summary Score \\\u003C 45 or decline from baseline of \\>10 point (Unfavorable Outcome)\n\nScore Interpretation:\n\n0 to 25: Very poor to poor health 25 to 49: Poor to fair health 50 to 74: Fair to good health 75 to 100: Good to excellent health","Screening, 1-year, 2-year, At time of conversion to AVR from GDMT arm",{"measure":72,"description":16,"timeFrame":73},"Moderate or severe prosthetic valve regurgitation","Screening, Pre-discharge, 30-day, 6-month, 1- year, 1.5-year, 2-year, 2.5-year, 3-year, 5-year and 10-year",{"measure":75,"description":42,"timeFrame":76},"N-Terminal Pro B-type Natriuretic Peptide (NT-ProBNP) or BNP","Screening, Pre-discharge, 30-day, 6-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year and 5-year",{"measure":78,"description":16,"timeFrame":35},"New onset of atrial fibrillation or atrial flutter",{"measure":80,"description":81,"timeFrame":82},"Aortic valve replacement or reintervention","Aortic valve replacement or reintervention is defined as any surgical or transcatheter procedure performed to replace the native aortic valve with a prosthetic valve or to treat dysfunction of a previously implanted prosthetic aortic valve. This includes surgical aortic valve replacement (SAVR), transcatheter aortic valve implantation (TAVI), valve-in-valve TAVI, redo TAVI, or surgical replacement of a previously implanted transcatheter or surgical valve.","30-day, 6- month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year, 5-year and 10-year",{"measure":84,"description":16,"timeFrame":85},"Technical success","At exit from procedure room",{"measure":87,"description":16,"timeFrame":29},"Device success",{"allocation":89,"interventionModel":90,"interventionModelDescription":42,"primaryPurpose":91,"observationalModel":42,"timePerspective":42,"maskingInfo":92},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":93,"maskingDescription":42,"whoMasked":42},"NONE","Participants with symptomatic moderate aortic stenosis OR asymptomatic moderate aortic stenosis with evidence of cardiac damage as assessed by echocardiography core lab.",[96,99],{"label":97,"type":98,"description":42,"interventionNames":42},"Guideline-directed medical therapy","NO_INTERVENTION",{"label":100,"type":101,"description":42,"interventionNames":102},"Transcatheter Aortic Valve Implantation","EXPERIMENTAL",[103],"Device: Transcatheter aortic valve Implantation",[105],{"type":106,"name":107,"description":108,"armGroupLabels":109,"otherNames":42},"DEVICE","Transcatheter aortic valve Implantation","Myval THV Series will include Myval\u002FMyval Octacor\u002F OctaPro\u002FOctaPro+ THV or any subsequent advanced version commercially available at the investigator site.",[100],[111],{"name":112,"role":113,"phone":114,"phoneExt":42,"email":115},"Dr.Ashokkumar Thakkar, PhD. Clinical Pharmacology","CONTACT","+91-9879443584","landmark.2@merillife.com",{"type":117,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","100633871",false,"NCT07532317","Comparison of Myval THV Series With Guideline-Directed Medical Therapy in Participants With Moderate Aortic Stenosis","A Prospective, Multinational, Multicentre, Open-label, Randomized Trial to Evaluate Safety and Effectiveness of Meril's Myval Transcatheter Heart Valve (THV) Series Compared to Guideline-Directed Medical Therapy (GDMT) in Participants With Moderate Aortic Stenosis.","Inclusion Criteria:\n\nAll participants for this study must meet all of the following inclusion criteria:\n\n1. Participants with ≥ 65 years of age.\n2. Participant has provided written informed consent as approved Institutional Review Board (IRB)\u002FIndependent Ethics Committee (IEC)\u002FEthics Committee (EC) of the investigational site to participate in the study.\n3. Participant with moderate aortic stenosis, defined as one of the following\n\n   * Peak aortic jet velocity (Vmax) ≥ 3.0 m\u002Fs and \\\u003C 4.0 m\u002Fs, or\n   * Mean pressure gradient ≥ 25 mmHg and \\\u003C 40 mmHg AND\n\n   The participant must meet one of the following categories:\n\n   3.1.AVA \\> 1.0 - ≤ 1.5 cm²; OR\n\n   3.2.AVA ≤ 1.0 cm² (or AVAi ≤ 0.6 cm²\u002Fm²)\n\n   3.2.1 Left Ventricular Function and Flow Profile: It is defined as participants with peak aortic jet velocity (Vmax) ≥ 3.0 and \\\u003C 4.0 m\u002Fs or mean pressure gradient ≥ 25 and \\\u003C 40 mmHg, and in the presence of aortic valve area (AVA) ≤ 1.0 cm² (or AVAi ≤ 0.6 cm²\u002Fm²)\n\n   The participant must meet one of the following categories:\n\n   a.Normal-Flow, Preserved LVEF:\\*\n   * Stroke Volume Index (SVi \\> 35 ml\u002Fm²) and LVEF ≥ 50% then, perform CT aortic valve calcium score to confirm true moderate AS:\\\u003C1200 AU (female) or \\\u003C 2000 AU (male) OR b.Low-Flow, Preserved LVEF:\n   * SVi ≤ 35 ml\u002Fm² and LVEF ≥ 50%, then perform CT aortic valve calcium score to confirm true moderate AS: \\\u003C 1200 AU (female) or \\\u003C 2000 AU (male) OR c.Low-Flow, Reduced LVEF:\n   * SVi ≤ 35 ml\u002Fm² and LVEF \\\u003C 50%, then confirm contractile reserve on dobutamine stress echocardiography (DSE)\\^, defined as a ≥ 20% increase in stroke volume with; I.AVA \\> 1.0 and ≤ 1.5 cm² or II.AVA \\> 1.0 cm² then perform CT aortic valve calcium score to confirm true moderate AS: \\\u003C 1200 AU (female) or \\\u003C 2000 AU (male) \\^ If DSE is not feasible or inconclusive, CT calcium scoring will be considered, with thresholds of \\\u003C 1200 AU for female and \\\u003C 2000 AU for male to identify Moderate AS participants.\n\n     * Not applicable for asymptomatic participants as asymptomatic with SVi \\> 35 are excluded.\n4. Moderate AS participants with symptoms:\n\n   1. Evidence of symptoms:\n\n      I.NYHA class ≥ II# and II.Chronic Dyspnea or III.Angina (CCS ≥ II) or IV.Cardiac Syncope\n\n      OR\n   2. Asymptomatic moderate AS participants with at least one of the evidence of cardiac damage\u002Fdysfunction:\n\nI.Participant with left ventricle ejection fraction ≤ 50% or\n\nII.Diastolic dysfunction ≥ Grade II or\n\nIII.Stroke Volume Index ≤ 35 ml\u002Fm² or\n\nIV.Persistent Atrial Fibrillation (AF) lasting from past 6 months or Paroxysmal Atrial Fibrillation episode within 6 months prior to consent or\n\nV.NT-proBNP ≥ 200 pg\u002Fml or ng\u002Fl or ≥ 200000 µg\u002Fl (or BNP ≥ 50 pg\u002Fml or ng\u002Fl or ≥ 50000 µg\u002Fl) or\n\nVI.LV mass index \\> 95 g\u002Fm² for female and \\> 115 g\u002Fm² for male (To detect LV hypertrophy) or\n\nVII.LV dimension or\n\n1. LV systolic diameter \\> 4 cm or \\> 40 mm for male and \\> 3.5 cm or 35 mm for female or\n2. LV diastolic diameter \\> 5.8 cm or \\> 58 mm for male and \\> 5.2 cm or 52 mm for female\n\nVIII.LV volume\n\n1. LV systolic volume \\> 61 mL or cm3 for male and \\> 42 mL or cm3 for female or\n2. LV diastolic volume \\> 150 mL or cm3 for male and \\> 106 mL or cm3 for female\n\n   * Only 10% of total study participants with NYHA class IV will be included in the trial.\n\nExclusion Criteria:\n\n1. Participants with moderate aortic stenosis undergoing concomitant CABG or surgical intervention on the ascending aorta or another valve.\n2. Aortic valve is unicuspid or non-calcified as verified by echocardiography\u002FCT.\n3. Renal insufficiency with glomerular filtration rate (GFR) \\\u003C 30 mL\u002Fmin and\u002For need for renal replacement therapy.\n4. Participants with ≥ moderate concomitant aortic regurgitation (≥ 3 grade).\n5. Participants with severe aortic stenosis.\n6. Moderate or severe mitral\u002Ftricuspid regurgitation (≥ 3 grade).\n7. Participants with pre-existing mechanical or bioprosthetic aortic valve.\n8. Left ventricle ejection fraction ≤ 20%.\n9. Severe left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak post-TAVI.\n10. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation.\n11. Previous stroke with permanent disability (modified Rankin score ≥ 2).\n12. Life expectancy \\\u003C 24 months due to non-cardiac co-morbid conditions including carcinomas, chronic liver disease, chronic renal disease or chronic end-stage pulmonary disease.\n13. Currently participating in an investigational drug or another device study where the primary endpoint is not achieved.\n14. Any condition, which in the Investigator's opinion, would preclude safe participation of participants in the study (e.g. psychiatric, alcoholism).\n15. TAVI unsuitable via transfemoral route.","ALL","65 Years",{"count":127,"type":128},778,"ESTIMATED","INTERVENTIONAL",[131],"NA","The primary objective of this trial is to evaluate the safety and effectiveness of Meril's Myval THV series in comparison to Guideline-Directed Medical Therapy in participants with moderate aortic stenosis. The trial includes a total of 778 participants (389:389) from approximately 50 investigator sites globally.",[134],"Moderate Aortic Stenosis",[136,137,138,139,140,141,142,143,144,145,146,147],"Cardiac Damage","Effectiveness","Guideline Directed Medical Therapy","Left ventricular ejection fraction","Low-flow, low-gradient aortic stenosis","Transcatheter Heart Valve THV)","Moderate aortic stenosis","Myval THV series","Myval THV","Myval Octacor THV","Myval OctaPro THV","Myval OctaPro+ THV","NOT_YET_RECRUITING","2026-04-29",{"date":151,"type":152},"2026-05-06","ACTUAL",{"date":154,"type":128},"2026-05-17",{"date":156,"type":128},"2041-05-12",{"name":5,"class":6}]