[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602458":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":27,"collaborators":20,"id":29,"slug":30,"hasResults":31,"nctId":32,"briefTitle":33,"officialTitle":34,"acronym":20,"eligibilityCriteria":35,"healthyVolunteers":31,"sex":36,"minAge":37,"maxAge":20,"enrollmentInfo":38,"targetDuration":20,"studyType":41,"phases":42,"briefSummary":44,"conditions":45,"keywords":49,"overallStatus":53,"whyStopped":20,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":20},{"fullName":5,"class":6},"Suzhou Hearthill Medical Technology Co.,LTD","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental group(PoliaValve)","EXPERIMENTAL","Patients receiving the PoliaValve (Aortic) from HearrHill Medical",[13],"Device: PoliaValve (Aortic)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","PoliaValve (Aortic)","Aortic Valve Replacement",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Kevin Yan","CONTACT","(+86)021-68248839","kevin.yan@hearthillmedical.com",{"type":28,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100602458","clinical-investigation-for-the-poliavalve-aortic-heart-valve--india-100602458",false,"NCT07123766","Clinical Investigation for the PoliaValve Aortic Heart Valve- India","A Prospective, Multicenter, Single-Arm Study With Objective Performance Criteria Evaluating the Efficacy and Safety of PoliaValve® Artificial Heart Valve","Inclusion Criteria:\n\n* Is 45 years or older\n* Provide written informed consent prior to trial procedures after standard of care studies and tests indicate that the patient needs aortic valve replacement\n* Agrees to attend all follow-up assessments for up to 1 year and is willing to comply with specified follow-up evaluations for the clinical trial\n* Diagnosed with severe symptomatic aortic valve stenosis and\u002For regurgitation\n\nExclusion Criteria:\n\n* Requires multiple valve replacement \u002F repair\n* Requires emergency surgery\n* Has had prior valve surgery\n* Requires a surgical procedure outside of the cardiac area\n* Requires a cardiac procedure other than a CABG or root enlargement or aortic root replacement\n* Requires or are planning another unrelated surgery within 12 months of undergoing implantation of the study device\n* Has active endocarditis\u002Fmyocarditis or within 3 months to the scheduled surgery\n* Has renal insufficiency as determined by creatinine (S-Cr) level as ≥ 1.5 mg\u002Fdl or end-stage renal disease requiring chronic dialysis at screening visit\n* Has MRI or CT scan confirmed stroke, cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 3 months (90 days) prior to planned valve surgery\n* Has acute myocardial infarction (AMI) within 30 days prior to planned valve surgery\n* Has life expectancy to less than 12 months\n* Diagnosed with hypertrophic obstructive cardiomyopathy (HOCM), except patients who have isolated subaortic muscular hypertrophy diagnosed at the time of surgery\n* Diagnosed with abnormal calcium metabolism and\u002For hyperparathyroidism\n* Echocardiographic left ventricular ejection fraction \\\u003C25%\n* Echocardiographic evidence of an intra-cardiac thrombus or vegetation\n* Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to planned valve surgery\n* Documented leukopenia (WBC \\\u003C 4.0 x 103\u002FµL), acute anemia (Hgb \\\u003C 10.0 gm\u002Fdl or 6 mmol\u002FL), thrombocytopenia (platelet count \\\u003C 100 x103\u002FµL) or history of bleeding diathesis or coagulopathy\n* Has prior organ transplant or is currently an organ transplant candidate\n* Current or recent participation (within 6 weeks prior to surgery) in another drug or device trial\n* Pregnant, lactating or planning to become pregnant during the duration of participation in trial\n* Currently incarcerated or unable to give voluntary informed consent\n* Documented history of substance (drug or alcohol) abuse within the last 5 years prior to implant\n* Requires concomitant left ventricular assist device (LVAD) placement, Impella placement, and\u002For intra-aortic balloon pump\n* Currently has uncontrolled infection\n* Currently diagnosed as uncontrolled diabetes mellitus (Random BLS \\> 300 mg\u002Fdl)","ALL","45 Years",{"count":39,"type":40},50,"ESTIMATED","INTERVENTIONAL",[43],"NA","The purpose of this study is to conduct a clinical investigation of the HeartHill PoliaValve Aortic Valve to collect evidence on the device's safety and performance.",[46,47,48],"AORTIC VALVE DISEASES","Aortic Valve Stenosis","Aortic Valve Regurgitation",[50,48,51,52],"Heart Valve Diseases","Aortic Valve Disease","Polymeric Aortic Valve","NOT_YET_RECRUITING","2025-08-08",{"date":56,"type":57},"2025-08-14","ACTUAL",{"date":59,"type":40},"2025-11-15",{"date":61,"type":40},"2027-12-30",{"name":5,"class":6}]