[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Meril Life Sciences Pvt. Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":149},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,52,76,104,124],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":4},"100633871","comparison-of-myval-thv-series-with-guideline-directed-medical-therapy-in-participants-with-moderate-aortic-stenosis-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":19,"type":20},778,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26],"Moderate Aortic Stenosis",[28,29,30,31,32,33,34,35,36,37,38,39],"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":43,"type":44},"2026-05-06","ACTUAL",{"date":46,"type":20},"2026-05-17",{"date":48,"type":20},"2041-05-12",{"name":50,"class":51},"Meril Life Sciences Pvt. Ltd.","INDUSTRY",{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":16,"minAge":59,"maxAge":4,"enrollmentInfo":60,"targetDuration":62,"studyType":63,"phases":4,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":4},"100622091","safety-and-performance-of-dafodil-heart-valves-in-real-world-aortic-and-mitral-valve-replacement-100622091","NCT07379112","Safety and Performance of Dafodil Heart Valves in Real-World Aortic and Mitral Valve Replacement","A Prospective, Multi-centre, Single-arm Registry to Evaluate the Safety and Performance of Dafodil™ Pericardial Bioprosthesis Series in Participants Undergoing Native\u002FProsthetic Aortic or Mitral Valve Replacement in Real World Settings","Inclusion Criteria:\n\n* Participant ≥18 years of age\n* Participants whose valvular disease is sufficiently advanced to warrant replacement of their natural\u002Fprosthetic aortic or mitral valve with Dafodil pericardial bioprosthesis series\n* Participants who are willing to undergo all protocol specific study procedures and follow-up requirements\n\nExclusion Criteria:\n\n* Participants who are not willing to provide informed consent form, or whose legal heirs object to their participation in the registry\n* Participant with active endocarditis, active myocarditis or other systemic infection\n* Participants undergoing double valve replacement (DVR)\n* Any condition, which, in Investigator's opinion would preclude safe participation of participants in the registry","18 Years",{"count":61,"type":20},500,"5 Years","OBSERVATIONAL","This study, called the EuroDafodil Registry, is being conducted to understand how safe and effective the Dafodil™ and Dafodil Neo™ Pericardial Bioprosthetic heart valves are when used in routine medical practice.\n\nThe registry includes adult patients (18 years or older) who require surgical replacement of their aortic or mitral heart valve, either because their natural valve is severely diseased or because a previously implanted valve is no longer working properly. All patients in this registry will receive a Dafodil™ heart valve as part of their standard surgical treatment. No experimental procedures are involved beyond usual clinical care.\n\nThis is a prospective, multi-centre registry being conducted at approximately 50 hospitals across Europe, with a planned enrollment of at least 500 patients. The study does not compare treatments; instead, it follows patients who receive the Dafodil™ valve to collect real-world information on outcomes.\n\nDoctors will monitor patients during their hospital stay and through regular follow-up visits at 1 or 3 months, 1 year, 3 years, and up to 5 years after surgery. Information collected includes survival, heart valve function, complications such as blood clots or infections, heart performance on echocardiography, and quality of life.\n\nParticipation in this registry is voluntary. All patients must provide written informed consent before joining. Patient privacy will be protected: personal identifiers will not be shared, and data will be coded so individuals cannot be directly identified.\n\nThe results of this registry will help doctors and health authorities better understand the long-term safety, performance, and durability of the Dafodil™ heart valves in real-world clinical use.",[66,67],"Aortic Valve Disease, Mitral Valve Disease, Prosthetic Heart Valve Dysfunction","Valvular Heart Disease Requiring Surgical Aortic or Mitral Valve Replacement","2026-01-31",{"date":70,"type":44},"2026-02-03",{"date":72,"type":20},"2026-04-01",{"date":74,"type":20},"2033-12-01",{"name":50,"class":51},{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":59,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":21,"phases":86,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},"100383674","landmark-trial-a-randomised-controlled-trial-of-myval-thv-100383674","NCT04275726","LANDMARK Trial: a Randomised Controlled Trial of Myval THV","A Prospective, Multinational, Multicentre, Open-label, Randomised, Non-inferiority Trial to Compare Safety and Effectiveness of Meril's Myval Transcatheter Heart Valve (THV) Series vs. Contemporary Valves (Edwards's Sapien THV Series and Medtronic's Evolut THV Series) in Patients With Severe Symptomatic Native Aortic Valve Stenosis","LANDMARK","Inclusion Criteria:\n\n1. Patient ≥18 years of age.\n2. Patient or their legal representative has provided written informed consent as approved by the Institutional Review Board (IRB)\u002FInstitutional Ethics Committee (IEC) of the investigational site to participate in the study.\n3. As per local Heart Team assessment, patient is eligible for TAVI and the patient is suitable for implantation with all three study devices.\n\nExclusion Criteria:\n\n1. Patients who are not willing to provide informed consent form, or whose legal heirs object to their participation in the study.\n2. Any condition, which in the Investigator's opinion, would preclude safe participation of patient in the study.",{"count":85,"type":20},988,[23],"The primary objective of this study (LANDMARK) is to compare the safety and effectiveness of the Myval THV Series with Contemporary Valves (Sapien THV Series and Evolut THV Series) in patients with severe symptomatic native aortic valve stenosis.\n\nThis study will be done in total 768 subjects (384:384, Myval THV Series vs. Contemporary Valves)\n\nThe randomisation will be carried out with an allocation ratio of 1:1 between Myval THV Series vs. Contemporary Valves (Sapien THV Series and Evolut THV Series)",[89],"Aortic Valve Stenosis",[91,92,93],"LANDMARK Trial","Trial to evaluate safety & effectiveness of Myval THV","CE Approved Myval THV Series","RECRUITING","2025-04-01",{"date":97,"type":44},"2025-04-04",{"date":99,"type":44},"2020-11-04",{"date":101,"type":20},"2033-12-31",{"name":50,"class":51},54,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":59,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},"100416517","myval-global-study-of-myval-thv-series-implanted-in-patients-with-native-severe-aortic-valve-stenosis-100416517","NCT04703699","Myval Global Study of Myval™ THV Series Implanted in Patients With Native Severe Aortic Valve Stenosis.","A Retrospective, Multinational, Multicentre, Observational Study in Patients Presenting With Native Severe Aortic Valve Stenosis and Treated With Myval™ Transcatheter Heart Valve Series in Real-world Setting.","Inclusion Criteria:\n\n* All patients of this study must have received Myval™ THV series for treatment of native severe aortic stenosis and completed a minimum of 30-day follow-up.\n\nExclusion Criteria:\n\n* No",{"count":112,"type":20},200,"A retrospective, multinational, multicentre, observational study in patients presenting with native severe aortic valve stenosis and treated with Myval™ Transcatheter Heart Valve Series in real-world setting.",[89],"2024-02-29",{"date":117,"type":44},"2024-03-04",{"date":119,"type":44},"2020-08-07",{"date":121,"type":20},"2028-11-30",{"name":50,"class":51},8,{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":59,"maxAge":132,"enrollmentInfo":133,"targetDuration":4,"studyType":21,"phases":135,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":4},"100365080","freedom-total-knee-system-for-treatment-of-osteoarthritis-rheumatoid-arthritis-or-post-traumatic-arthritis-100365080","NCT04033588","Freedom® Total Knee System for Treatment of Osteoarthritis, Rheumatoid Arthritis or Post-traumatic Arthritis","A Prospective, Multi-centre, Non-comparative, Post-market Clinical Follow-up Study to Evaluate the Survivorship, Safety and Performance of the Freedom® Total Knee System in United Kingdom.","Freedom®450","Inclusion Criteria:\n\n* Male and female subjects aged between 18 years and 75 years.\n* Subjects who require unilateral knee prosthesis and have been evaluated as appropriate candidates for a total knee replacement by the investigator.\n* Subjects suffering from severe knee joint pain and loss of mobility due to rheumatoid arthritis, osteoarthritis or post-traumatic osteoarthritis.\n* Subjects, who in the opinion of the investigator are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow ups.\n* Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.\n\nExclusion Criteria:\n\n* Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation.\n* Subjects who are known drug or alcohol abuse or with psychological disorders that could affect follow-up care or treatment outcomes.\n* Subject with a known sensitivity to device materials.\n* Subjects with other significant disabling problems from the muscular-skeletal system other than in the knees (i.e muscular dystrophy, polio, neuropathic joints).\n* Subjects with a BMI of 40 or above.\n* Subjects with a current or active history of malignancy, active or suspected infection, Paget's disease, renal osteodystrophy, immunologically suppressed or have any other significant medical illness judged by investigator to exclude from study.\n* Subject with neuromuscular or neurosensory deficiency that may limit ability of the patient to evaluate the safety and efficacy of the device.\n* Female subjects who are pregnant or lactating.\n* Subjects who have previously undergone total or unicondylar knee replacement, high tibial osteotomy, ligament reconstruction, open reduction internal fixation (ORIF) or with previous fracture in the ipsilateral knee joint.","75 Years",{"count":134,"type":20},450,[23],"A prospective, multi-centre, non-comparative, post-market clinical follow-up study to evaluate the survivorship, safety and performance of the Freedom® Total Knee System in the treatment of approximately 450 subjects who in the surgeon's opinion require a primary total knee replacement due to severe knee joint pain and loss of mobility due to osteoarthritis, rheumatoid arthritis or post-traumatic arthritis at upto 15 centers in the United Kingdom (UK). The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Freedom® Total Knee System used in total knee replacement. Subjects must meet all the study inclusion \u002F exclusion criteria before enrolment in the study. Subjects will be requested to attend out-patients clinic for clinical follow-up (CFU) or approached for telephonic follow-up (TFU) post-operatively as mentioned below.\n\nClinical \\& Telephonic Follow-up details:\n\n* 6-8 weeks ± 1week (Clinical follow-up)\n* 1 year ± 1 month (Clinical follow-up)\n* 3 years ± 6 months (Clinical follow-up)\n* 5 years ± 6 month (Clinical follow-up (optional) \u002F Telephonic follow-up)\n* 10 years± 6 month (Clinical follow-up (optional) \u002F Telephonic follow-up)",[138,139,140],"Knee Osteoarthritis","Rheumatoid Arthritis","Post-traumatic Osteoarthritis","2020-10-01",{"date":143,"type":44},"2020-10-05",{"date":145,"type":20},"2021-01-01",{"date":147,"type":20},"2032-09-01",{"name":50,"class":51},""]