[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Venus MedTech (HangZhou) Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":109},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,36,63,87],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":4,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":25,"lastUpdatePostDateStruct":26,"startDateStruct":29,"completionDateStruct":31,"leadSponsor":33,"locationsCount":4},"100633793","venusp-valve-system-long-term-follow-up-6-10-years-100633793",false,"NCT07531303","VenusP-Valve™ System Long-term Follow-up 6-10 Years","Long-term Follow-up Study of Implantation of the VenusP-Valve™ in the Pulmonic Position in Patients With Native Outflow Tracts","Inclusion Criteria:\n\n* The subject or the subject's legal representative has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the ethics committee and regulatory authority if applicable of the respective clinical site\n\nExclusion Criteria:\n\n* The investigators consider that the patients are not suitable to participate in this study.","ALL",{"count":18,"type":19},55,"ESTIMATED","OBSERVATIONAL","The goal of this study is to assess the long-term safety, efficacy and performance of VenusP-Valve™ implantation. in all subjects who provided informed consent and received VenusP-Valve™ implantation in the VenusP-Valve™ system CE registration study (Protocol ID Number: VMT-001CE; NCT02846753).\n\nAnnual clinic visits will be conducted from year 6 through year 10 post-implantation, including transthoracic echocardiography, New York Heart Association (NYHA) functional classification assessment, adverse event evaluation, and review of cardiovascular medication use at each visit..",[23],"Native Right Ventricle Outflow Tract(RVOT) Dysfunction","NOT_YET_RECRUITING","2026-04-08",{"date":27,"type":28},"2026-04-15","ACTUAL",{"date":30,"type":19},"2026-05",{"date":32,"type":19},"2030-06",{"name":34,"class":35},"Venus MedTech (HangZhou) Inc.","INDUSTRY",{"id":37,"slug":38,"hasResults":11,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":42,"eligibilityCriteria":43,"healthyVolunteers":11,"sex":16,"minAge":44,"maxAge":4,"enrollmentInfo":45,"targetDuration":4,"studyType":47,"phases":48,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":62},"100516901","venusp-valve-pivotal-study-proteus-study-100516901","NCT06010563","VenusP-Valve Pivotal Study (PROTEUS STUDY)","Evaluation of the Performance of the VenusP-ValveTM System in Patients with Native RVOT Dysfunction","PROTEUS","Inclusion Criteria:\n\n1. Weight ≥25kg (55 lbs.)\n2. Age ≥ 12 years olds\n3. Patients have a dysfunctional native RVOT with severe pulmonary regurgitation (i.e., severe pulmonary regurgitation as determined by echocardiography or pulmonary regurgitant fraction ≥30% as determined by cardiac magnetic resonance imaging) and without significant pulmonary stenosis (significant pulmonary stenosis is defined as gradient more than 25mmHg) and are clinically indicated for intervention:\n\n1\\) For symptomatic patients, fitting the following criteria:\n\n* Severe pulmonary regurgitation measured by echocardiogram or pulmonary regurgitant fraction ≥30% measured by CMR 2) For asymptomatic patients, including any 2 of the following criteria:\n* Mild or moderate RV or LV systolic dysfunction.\n* Severe RV dilation (RVEDVI ≥145 mL\u002Fm2 or RVESVI ≥ 75 mL\u002Fm2or RVEDV \\>2 × LVEDV).\n* Progressive reduction in objective exercise tolerance. 4. Patient is willing to consent to participate in the study and will commit to completion of all follow-up requirements.\n\nExclusion Criteria:\n\n1. Clinical or biological signs of infection including active endocarditis.\n2. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.\n3. Leukopenia, anemia, thrombocytopenia, or any known blood clotting disorder, deemed clinically significant after consultation with Haemato-oncology specialists.\n4. Inappropriate anatomy for femoral or right internal jugular vein (RIJ) introduction and delivery of the VenusP-ValveTM System.\n5. RVOT anatomy or morphology that is unfavorable for device anchoring.\n6. Anatomy unable to accommodate VenusP-Valve delivery system.\n7. Angiographic evidence of coronary artery compression that would result from transcatheter pulmonary valve replacement (TPVR).\n8. Emergency interventional\u002Fsurgical procedures within 30 days prior to the index procedure.\n9. Planned significant and relevant concomitant procedure at time of VenusP-Valve implant.\n10. Any planned interventional\u002Fsurgical procedures to be performed within the 30 days follow-up from VenusP-Valve implant.\n11. Known history of intravenous drug abuse in the past 5 years, without certificate of completion of rehabilitation from a specialist.\n12. Major or progressive non-cardiac disease resulting in a life expectancy of less than one year.\n13. Known hypersensitivity or contraindication to antiplatelet, antithrombotic medications, or nitinol (titanium or nickel) leading to be unable to undergo index procedure per physicians' judgement\n14. Positive pregnancy test at baseline (prior to CT angiography and again prior to implant procedure) in female patients of child-bearing potential.\n15. Currently participating in an investigational drug or another device study.\n16. Patient or guardian unwilling or unable to provide written informed consent or comply with follow-up requirements.\n17. The investigators consider that the patients are not suitable to participate in this research.","12 Years",{"count":46,"type":19},60,"INTERVENTIONAL",[49],"NA","A prospective, multi-center, non-randomized interventional study to evaluate the safety and effectiveness of the VenusP-ValveTM System in patients with native right ventricular outflow tract (RVOT) dysfunction.\n\nPost procedure, a clinical visit will be scheduled at pre-discharge, 30 days, 6 months, 12 months, and annually thereafter to 10 years.\n\nAbout 60 subjects will be enrolled in this study. Data analysis will be performed after all enrolled subjects complete 6-month follow-up and the primary endpoint analysis report will be submitted to FDA for PMA approval.",[52],"Pulmonary Regurgitation","RECRUITING","2025-02-25",{"date":56,"type":28},"2025-02-28",{"date":58,"type":28},"2024-06-11",{"date":60,"type":19},"2034-08-30",{"name":34,"class":35},1,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":44,"maxAge":71,"enrollmentInfo":72,"targetDuration":74,"studyType":20,"phases":4,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},"100503445","observational-study-of-venus-p-valve-100503445","NCT05835349","Observational Study of Venus P-Valve","A Real-World Evidence Observational Study of VenusP-ValveTM System in the Treatment of Patients with Native RVOT Dysfunction","Registry","Inclusion Criteria\n\n1. Patients with native RVOT (including transvalvular patch repair) are present with moderate or greater pulmonary regurgitation with\u002Fwithout stenosis and are clinically indicated for pulmonary valve intervention.\n2. The patient (or the patient's legally authorized representative) is willing to consent to participate in the study and will commit to completing all follow-up requirements.\n\nExclusion Criteria:\n\n1\\. Patients with any condition contraindicated by the IFU or inability to comply with the Venus P-ValveTM System Instructions for Use or the study protocol.","70 Years",{"count":73,"type":19},200,"5 Years","Real-world evidence, retrospective and prospective, non-randomized, multicenter observational study of VenusP-ValveTM System in treating moderate or greater pulmonary regurgitation with\u002Fwithout pulmonary stenosis in patients with native right ventricular outflow tract (RVOT).",[77],"Right Ventricular Outflow Tract Dysfunction","2025-01-21",{"date":80,"type":28},"2025-01-24",{"date":82,"type":28},"2024-08-26",{"date":84,"type":19},"2032-12",{"name":34,"class":35},10,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":94,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":47,"phases":97,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":4},"100515420","venus-vitae-pivotal-study-smart-align-study-100515420","NCT05991271","Venus-Vitae Pivotal Study Smart-Align Study","Multicenter Pivotal Study to Evaluate the Treatment of Severe Aortic Valve Stenosis With Next-Generation Venus-Vitae Transcatheter Heart Valve (THV) System","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Patients with the symptoms of severe aortic stenosis\n3. Severe aortic stenosis (AS, grade 3+), defined as AVA ≤ 1 cm2 (AVAi ≤ 0.6 cm2\u002Fm3) or Vmax ≥ 4.0 m\u002Fs or MPG ≥ 40 mmHg determined by echocardiography\n4. Patients deemed for cardiac intervention by a heart team\n5. Patients of all surgical risk categories can be enrolled in this study, but should follows local medical practices and regulatories.\n6. Patients or their legal reprensentatives are willing to participate in the study and provide written informed consent, and agree to follow the follow-up requirements\n\nExclusion Criteria:\n\nA subject meeting any of the following criteria shall be excluded:\n\nCo-morbidities\n\n1. Previous mechanical or biological aortic valve replacement\n2. Untreated mitral, tricuspid or pulmonary valve diseases requiring procedural intervention\n3. Acute myocardial infact within 30 days prior to index procedure\n4. Untreated clinical significant coronary artery disease requiring revascularization\n5. Any therapeutic invasive cardiac procedure performed within 30 days (or drug-eluting coronary stent\u002Fscaffold implant within 6 months)\n6. Sever symptomatic carotid artery stenosis\n7. Stroke or TIA within 3 months or Modified Rankin Scale ≥ 4 disability\n8. Chronic kidney disease (eGFR\\\u003C30 mL\u002Fmin\u002F1.73m2)\n9. Haemotologic disorders: Leukopenia (WBC \\\u003C 3000 cell\u002FmL), anemia (Hgb \\\u003C 9 g\u002FdL), thrombocytopenia (Plt\\\u003C 50,000 cell\u002FmL), or any known blood clotting disorder, deemed clinically significant after consultation with Haematooncology specialists\n10. Severe right heart dysfunction Anatomical\n11. LVEF \\\u003C 20%\n12. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation\n13. Inappropriate anatomy for femoral introduction and delivery of study device\n14. Native aortic valve geometry and size unfavorable for study device anchoring General\n15. Haemodynamics instability requiring inotropic support or intra-aortic balloon pump (IABP) or other hemodynamic support device, or any mechanical heart assistance\n16. Known hypersensitivity or contraindication to antiplatelet, antithrombotic medications, or cobalt-chromium leading to be unable to undergo index procedure per physicians' judgement\n17. Life expectancy ≤ 1 year due to noncardiac reasons\n18. Active infection requiring antibiotic therapy including infective endocarditis\n19. Planned relevant concomitant procedure within 30 days post index procedure\n20. Pregnant, breastfeeding or intend to become pregnant within 1 year","18 Years",{"count":96,"type":19},150,[49],"The purpose is to evaluate the safety, effectiveness and performance of Venus-Vitae Transcatheter Heart Valve System in patients with severe aortic stenosis.",[100],"Aortic Valve Stenosis","2023-08-14",{"date":103,"type":28},"2023-08-18",{"date":105,"type":19},"2023-10-31",{"date":107,"type":19},"2029-06-30",{"name":34,"class":35},""]