[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Suzhou Hearthill Medical Technology Co.,LTD\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":91},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,73],{"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":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"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":19,"type":20},50,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28],"AORTIC VALVE DISEASES","Aortic Valve Stenosis","Aortic Valve Regurgitation",[30,28,31,32],"Heart Valve Diseases","Aortic Valve Disease","Polymeric Aortic Valve","NOT_YET_RECRUITING","2025-08-08",{"date":36,"type":37},"2025-08-14","ACTUAL",{"date":39,"type":20},"2025-11-15",{"date":41,"type":20},"2027-12-30",{"name":43,"class":44},"Suzhou Hearthill Medical Technology Co.,LTD","INDUSTRY",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":4},"100574096","clinical-trial-of-ventiflow-lp-supporting-high-risk-percutaneous-coronary-interventionpci-100574096","NCT06754839","Clinical Trial of Ventiflow LP Supporting High-risk Percutaneous Coronary Intervention(PCI)","Clinical Trial Evaluating the Effectiveness and Safety of Percutaneous Left Ventricular Assist Device in Supporting High-risk Percutaneous Coronary Intervention","Inclusion Criteria:\n\n1. 18 Years to 90 Years\n2. The cardiac team determined that the subject needs coronary artery revascularization, but there is a higher risk of CABG, or the subject refuses to accept CABG. After comprehensive evaluation by the cardiac team, it was determined that the subjects could benefit from PCI\n3. The subject is diagnosed with acute or chronic coronary syndrome, and\n\n   1. LVEF≤ 35% or\n   2. LVEF ≤ 40% and NYHA Classification is III or IV\n4. Informed consent\n5. The participant meets all the above clinical inclusion criteria and must comply with at least one of the following imaging criteria.\n\n1\\. At least two coronary artery CTOs (diameter of occluded artery ≥ 2.5mm) 2. Unprotected left main coronary artery disease, and meeting one or more complex operating standards 3. Three-vessel disease and meeting two or more complex operating standards\n\nComplex operations are defined as:\n\n1. Bifurcation lesions require treatment of dual branches (including stents and PTCA)\n2. Calcification lesions require complex operation or instrument assistance (Excimer laser coronary atherectomy, intravascular lithotripsy, or rotational atherectomy)\n3. Severe distortion requires complex operations\n4. The target lesion is CTO (diameter of occluded artery ≥ 2.5mm and J-CTO score ≥ 2 )\n\nExclusion Criteria:\n\n1. Acute ST-elevation myocardial infarction within 7 days or receiving thrombolytic therapy;\n2. Cardiopulmonary resuscitation within 24 hours;\n3. Patients who have had cardiogenic shock (systolic blood pressure \\\u003C 90 mmHg for more than 30 minutes or need catecholamines to maintain systolic blood pressure above 90 mmHg) or hemodynamic instability within 7 days before surgery;\n4. Atrial or ventricular septal defect (including post-infarct VSD), left ventricular wall thrombus; left ventricular rupture, cardiac tamponade, or concomitant cardiopulmonary failure;\n5. Presence of aortic stenosis\u002Fcalcification (aortic orifice area ≤ 0.6cm2), documented moderate to severe aortic regurgitation (echocardiographic assessment grade ≥2+); have an artificial aortic valve;\n6. Severe pulmonary hypertension, right heart failure or severe tricuspid regurgitation;\n7. Prior or current use of a persistent left ventricular assist device (LVAD), or use of IABP, extracorporeal membrane oxygenation (ECMO), or percutaneous ventricular assist device (such as Impella or Tandem Heart) within 7 days prior to surgery;\n8. History of stroke or transient ischemic attack within 1 month before surgery;\n9. Patients with renal failure (creatinine ≥3 times ULN) and may require dialysis treatment;\n10. Subject has abnormal liver function (elevated aspartate aminotransferase (AST), alanine aminotransferase (ALT) and bilirubin levels ≥3 times ULN);\n11. Moderate and severe anemia (hemoglobin \\\u003C90g\u002FL); Subject has abnormalities in coagulation parameters that cannot be corrected (defined as platelet count ≤ 75×109\u002FL or INR ≥2.0 or fibrinogen ≤1.50g\u002Fl); or inability to be treated with antiplatelet agents and anticoagulants;\n12. Active visceral hemorrhage within 1 month;\n13. History of allergy to heparin, contrast media, etc.;\n14. Aortic abnormalities that preclude surgery, including aneurysms, extreme curvature, or calcification; or known severe arterial disease that precludes the trial, such as aortic dissection, Marfan syndrome, etc.;\n15. Severe peripheral arterial obstructive disease (stent, tortuosity, stenosis, dissection, etc.) that prevents study device placement;\n16. Infection at the site of the planned surgical puncture site or suspected active systemic infection with fever or need for antibiotic therapy;\n17. Pregnant women and lactating women;\n18. The subject has participated in other medical device clinical trials\u002Fdrug clinical trials during the same period;\n19. ECMO cannot be implanted or there are contraindications to its application and any other conditions that the investigator considers inappropriate to participate in this trial.","18 Years","90 Years",{"count":55,"type":20},250,[23],"The purpose of this prospective, multicenter, randomized controlled clinical trial is to evaluate the effectiveness of the transcatheter left ventricular assist system (Ventiflow LP) in providing circulatory support to patients during high-risk PCI procedures compared to veno-arterial extracorporeal membrane oxygenation (VA-ECMO).The participants will be randomly assigned to the experimental group or the control group after enrollment, and will undergo percutaneous coronary intervention(PCI) with support from Ventiflow LP or VA-ECMO respectively. All participants need to undergo a 3-month follow-up after operative.",[59,60,61],"Coronary Artery Disease","Heart Failure","High-risk PCI",[61,63,64],"Percutaneous left ventricular assist device","heart failure","2024-12-23",{"date":67,"type":37},"2025-01-01",{"date":69,"type":20},"2024-12",{"date":71,"type":20},"2025-12",{"name":43,"class":44},{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":88,"leadSponsor":90,"locationsCount":4},"100572783","clinical-trial-evaluating-the-safety-and-efficacy-of-artificial-polymer-heart-valve-for-the-treatment-of-aortic-valve-disease-100572783","NCT06737757","Clinical Trial Evaluating the Safety and Efficacy of Artificial Polymer Heart Valve for the Treatment of Aortic Valve Disease","Prospective, Multicenter, Randomized Controlled, Non-Inferiority Clinical Trial Evaluating the Safety and Efficacy of Artificial Polymer Heart Valve for the Treatment of Aortic Valve Disease","Inclusion Criteria:\n\n1. The subjects are aged ≥18 years old;\n2. The subjects understand the nature and purpose of the study, voluntarily participate, and sign the informed consent form. They agree to comply with the trial requirements, cooperate with surgical treatment and follow-up, and consent to relevant follow-up inquiries and examinations;\n3. The subjects have been confirmed to have severe aortic valve stenosis and\u002For regurgitation (also known as insufficiency) through echocardiography;\n4. According to the 2020 ACC\u002FAHA guidelines for the management of patients with valvular heart disease, the subjects meet the indications for surgical aortic valve replacement and preoperative assessment recommends surgical aortic valve replacement.\n\nExclusion Criteria:\n\n1. Other valve diseases with surgical indications, such as severe mitral regurgitation, severe tricuspid regurgitation, moderate or greater mitral stenosis, or a history of previous aortic or other valve replacement surgery;\n2. Other severe cardiovascular conditions with surgical indications, such as Stanford A-type aortic dissection, aortic sinus aneurysm (sinus diameter \\> 5.0cm), hypertrophic obstructive cardiomyopathy, diffuse three-vessel coronary artery disease, or placement of a left ventricular assist device in end-stage heart failure;\n3. End-stage heart failure that is not reversible even with aortic valve surgery, such as severe left ventricular dysfunction (LVEF \\\u003C 25%), or severe heart failure that cannot be corrected, or severe pulmonary hypertension assessed by right heart catheterization, with planned postoperative Impella, IABP, or left ventricular assist;\n4. Preoperative decompensated heart failure, cardiogenic shock, malignant arrhythmias, etc., requiring mechanical circulatory support, mechanical ventilation, or emergency surgery;\n5. Active endocarditis within the past 3 months or the presence of cardiac vegetations;\n6. Severe acute myocardial infarction or history of cerebrovascular accidents within the past 3 months (excluding lacunar infarcts);\n7. Severe renal insufficiency (glomerular filtration rate \\\u003C 30mL\u002Fmin) or end-stage renal disease requiring long-term dialysis;\n8. Liver dysfunction or gastrointestinal malnutrition-related diseases;\n9. Active bleeding, bleeding tendencies, or patients unable to receive anticoagulant therapy;\n10. Severe respiratory or ventilatory dysfunction requiring continuous oxygen therapy;\n11. Poor compliance or cognitive impairment (such as coma, Parkinson's disease, dementia, substance abuse), inability to follow study requirements or refusal to participate in follow-up visits;\n12. Other conditions with an expected lifespan of less than 1 year, such as malignancies and immunodeficiency diseases;\n13. Other situations not suitable for artificial aortic valve replacement or participation in this trial.",{"count":81,"type":20},198,[23],"The purpose of this study is to conduct the clinical investigation of the HeartHill Medical's polymer aortic valve, namely PoliaVavle，to collect evidence on the device's safety and performance. This prospective, multicenter, randomized controlled, non inferiority clinical trial is expected to enroll 198 subjects and conduct a 1:1 random grouping. The experimental group will use polymer material surgical aortic valves（PoliaVavle, HeartHill Medical, Suzhou China) for aortic valve replacement, while the control group will use bovine pericardial biological valves for aortic valve replacement.",[27,31,28],{"date":86,"type":37},"2024-12-30",{"date":69,"type":20},{"date":89,"type":20},"2029-12",{"name":43,"class":44},""]