[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Peijia Medical Technology (Suzhou) Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":111},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,69,91],{"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":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100571547","study-of-transcatheter-aortic-valve-replacement-with-a-flex-and-commissural-alignment-technology-in-severe-aortic-stenosis-100571547",false,"NCT06721676","Study of Transcatheter Aortic Valve Replacement With A² Flex and Commissural Alignment Technology in Severe Aortic Stenosis","A Prospective, Single-center, Single-group Follow-up Study of Transcatheter Aortic Valve Replacement With A² Flex and Commissural Alignment Technology in Severe Aortic Stenosis by Peijia Medical","Inclusion Criteria:\n\n* Patients who are willing to participate and sign the informed consent and can cooperate with the whole trial process;\n* Age ≥60 years old;\n* Patients with severe calcified aortic stenosis confirmed by echocardiography (trans-aortic valve flow velocity ≥ 4.0m \u002Fs, or trans-active valvular pressure difference ≥40mmHg (1mmHg=0.133kPa), or aortic valve orientation area \\\u003C 0.8cm2, or effective aortic valve orifice the product index is \\\u003C 0.5cm2\u002Fm2);\n* The cardiac team (at least two specialists in cardiovascular surgery) assessed the patient as unsuitable for routine surgery ;\n* The aortic angel ≥60 degree.\n\nExclusion Criteria:\n\n* The left and right coronary ostiums originate from the junctional zone or from both coronary ostiums;\n* previous CABG history;\n* Coronary ostial lesions（PCI or not）;\n* Prior aortic valve prosthesis implantation (interventional\u002Fsurgical, bioprosthetic\u002Fmechanical);\n* Spoor peripheral arterial condition precluded transfemoral TAVR;\n* Severe coronary stenoses requiring intervention for which concomitant PCI is not possible;\n* Concomitant diseases requiring cardiac surgery;\n* Other serious diseases that may reduce life expectancy to less than 12 months (e.g. clinically recurrent or metastatic cancer, congestive heart failure, etc.);\n* contraindications to conventional cardiac catheterization, such as intracardiac thrombosis, infection, outflow obstruction, hypertrophic cardiomyopathy, etc;\n* other surgical anatomical contraindications, such as the risk of coronary artery occlusion;\n* clinically significant active bleeding\n* platelet count \\\u003C 30×10\u002F L;\n* participating in other drug or medical device clinical studies that have not yet been completed ;\n* considered inappropriate by the investigator to participate in the clinical study.","ALL","60 Years",{"count":19,"type":20},10,"ESTIMATED","INTERVENTIONAL",[23],"NA","A prospective, single-center, single-group follow-up study of transcatheter aortic valve replacement with A² Flex and commissural alignment technology in severe aortic stenosis by Peijia Medical",[26],"Aortic Stenosis Symptomatic",[28,29,30,31],"aortic stenosis","TAVI","TAVR","Function of bending","NOT_YET_RECRUITING","2024-12-03",{"date":35,"type":36},"2024-12-06","ACTUAL",{"date":38,"type":20},"2024-12",{"date":40,"type":20},"2025-06-30",{"name":42,"class":43},"Peijia Medical Technology (Suzhou) Co., Ltd.","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":44},"100489651","safety-and-efficacy-of-the-geminione-transcatheter-valve-edge-to-edge-repair-system-in-patients-with-moderate-severe-or-severe-degenerative-mitral-regurgitation-100489651","NCT05655897","Safety and Efficacy of the GeminiOne Transcatheter Valve Edge-to-Edge Repair System in Patients With Moderate-severe or Severe Degenerative Mitral Regurgitation","A Prospective, Multicentric Clinical Trial Protocol to Evaluate the Safety and Efficacy of the GeminiOne Transcatheter Valve Edge-to-Edge Repair System for the Treatment of Moderate-severe or Severe Degenerative Mitral Regurgitation With Single-arm Objective Performance Criteria","Inclusion Criteria:\n\n1. Patients who volunteer to participate and sign an informed consent form, understand the purpose of the clinical trial and are able to cooperate throughout the trial process;\n2. An age ≥ 18 years;\n3. Diagnostic transthoracic echocardiogram (TTE) obtained within 90 days and transesophageal echocardiogram (TEE) obtained within 180 days to determine the presence of symptomatic moderate-severe or severe degenerative mitral regurgitation (defined as mitral regurgitation grade ≥3+);\n4. Patients' New York Heart Association (NYHA) cardiac function classification (see Appendix II) in grades II, III, or non-ambulatory grade IV；\n5. Patients' left ventricular ejection fraction LVEF ≥ 20%;\n6. Patients considered to be at high surgical risk by the multidisciplinary cardiac team ;\n7. Patients are anatomically suitable for mitral valve repair and suitable for the device under this study as assessed by the multidisciplinary cardiac team;\n\nElements include, however, are not constrained to the following:\n\n1. Mitral valve orifice area ≥ 4.0 cm2;\n2. Left ventricular end-systolic dimension (LVESD) ≤ 60 mm;\n3. The primary regurgitant bundle is a non-conjunctive regurgitant bundle and if the secondary regurgitant bundle is present, must be clinically insignificant;\n4. Transeptal puncture and femoral venipuncture are feasible; The recommended reference criteria for high surgical risk are: an STS score of ≥8 for surgical valve replacement (see Appendix III) or an STS score of ≥6 for surgical valve repair, or the existence of other high-risk factors, such as the presence of other high-risk elements such as the presence of ≥ 2 warning signs of moderate-severe frailty or the presence of feasible surgical operative limitations or the presence of ≥ 2 main organs dysfunctions that cannot be elevated postoperatively or other surgical high-risk factors that are genuinely existing in the judgment of the independent cardiac surgeon in this study.\n\nExclusion Criteria:\n\n1. The presence of intra-cardiac space occupancy, thrombus, or bulky organisms as indicated by echocardiography;\n2. The presence of other severe heart valve diseases requiring surgical intervention;\n3. Leaflet anatomy that may prevent implantation of the valve clip, proper positioning on the leaflet, or prevent adequate reduction of mitral regurgitation by the valve clip. The assessment is based on transesophageal echocardiographic (TEE) mitral valve evaluation within 180 days prior to the subject's registration and includes:\n\n   1. inability of the valve clips to hold sufficient active leaflets;\n   2. lack of primary and secondary tendon support in the clamping area;\n   3. significant evidence of calcification in the clamping area;\n   4. significant fissures in the clamping area;\n4. Active endocarditis, pericarditis, or rheumatic heart disease; or mitral valve leaflet changes resulting from endocarditis or rheumatic heart disease;\n5. Severe right ventricular insufficiency (e.g. with symptoms of bilateral lower limb edema with increased jugular venous pressure and hepatomegaly); or pulmonary hypertension (pulmonary artery systolic pressure PASA \\> 70 mmHg as measured by echocardiography);\n6. Patients who have had an acute coronary syndrome within 4 weeks, or untreated severe coronary artery stenosis requiring revascularization;\n7. Patients with any cardiovascular intervention, cardiac surgery, cardiac resynchronization therapy (CRT, CRT-D), implantation of a buried cardioverter-defibrillator (ICD), etc. within 30 days; or have planned one of these procedures;\n8. Patients underwent mitral valve surgery or mitral transcatheter valve surgery before, or have a left atrial appendage occluder device inside；\n9. Patients with end-stage heart failure (ACC\u002FAHA stage D), or after cardiac transplantation, or awaiting cardiac transplantation;\n10. Patients who are hemodynamically unstable, defined as systolic blood pressure \\\u003C90 mmHg without postload-reducing drugs, or in cardiogenic shock; or are requiring intra-aortic balloon counterpulsation, or other hemodynamic support drugs or devices;\n11. Patients requiring emergency or urgent surgery for any reason;\n12. Patients' femoral vein cannot accommodate a 22F catheter or overlaying ipsilateral deep venous thrombosis, as assessed by the investigator, or are anatomically unsuitable for atrial septum puncture; \\[13\n13. Patients with active infection requiring concurrent antibiotic treatment; in the case of temporary disease, antibiotics must be discontinued for at least 14 days before enrollment;\n14. Patients with a history of any cerebrovascular accident within 30 days; or a severe symptomatic carotid stenosis (carotid ultrasound suggesting \\>70% stenosis);\n15. Modified Rankin Scale score ≥ 4 (see Annex IV);\n16. Patients with a history of acute peptic ulcer or gastrointestinal bleeding within 3 months;\n17. Patients with hematological cachexia, including granulocytopenia (WBC \\\u003C3 x 109\u002FL), anemia (HB \\\u003C 90 g\u002FL), thrombocytopenia (PLT \\\u003C50 x 109\u002FL), bleeding disorders, and coagulopathy; or the presence of contraindications to antiplatelet or anticoagulant medication;\n18. Patients with a contraindication to transesophageal echocardiography; or a contraindication to general anesthesia；\n19. Patients with severe chronic obstructive pulmonary disease (COPD) requiring long-term steroids or continuous home oxygen therapy；\n20. Patients with severe hepatic or renal insufficiency (ALT, AST, creatinine \\> 2 times the upper limit of normal values)；\n21. Pregnant or lactating women, or those with a birth plan within 12 months；\n22. Patients with known hypersensitivity to device components or contrast media；\n23. Patients enrolled in another clinical study and within the follow-up period；\n24. Patients with a disease that would make the evaluation of treatment difficult (e.g. cancer, infection, severe metabolic disease, psychiatric disease, etc.); or patients with a life expectancy shorter than 12 months；\n25. Patients whose compliance is assessed by the investigator to be poor and are unable to comply with the follow-up schedule and complete the examination; or other situations in which the investigator considers the issue to be unsuitable for participation in the study.","18 Years",{"count":54,"type":20},120,[23],"To observe and evaluate the safety and efficacy of the GeminiOne Transcatheter Valve Edge-to-Edge Repair System in Patients With Moderate-severe or Severe Degenerative Mitral Regurgitation through a prospective, multicenter clinical trial using objective performance criteria.",[58,59],"Mitral Regurgitation","Degenerative Mitral Valve Disease","RECRUITING","2024-06-04",{"date":63,"type":36},"2024-06-05",{"date":65,"type":36},"2022-11-24",{"date":67,"type":20},"2029-11-24",{"name":42,"class":43},{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":78,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},"100523913","safety-and-effectiveness-of-taurustrio-heart-valve-system-in-patients-with-severe-aortic-regurgitation-ar-100523913","NCT06101888","Safety and Effectiveness of TaurusTrio™ Heart Valve System in Patients With Severe Aortic Regurgitation (AR)","A Prospective, Multicenter, Single-group Clinical Study to Evaluate the Safety and Efficacy of Peijia Medical Transcatheter Aortic Valve System in the Treatment of Severe Aortic Valve Regurgitation","Inclusion Criteria:\n\n* Patients who voluntarily participate and sign the informed consent and are able to comply with the entire trial process;\n* Age ≥ 18 years;\n* Adult subjects with severe AR (Grade ≥ 3) as assessed by echocardiography based on ASE (American Society of Echocardiography) using multiparametric approach with:\n\n  * Jet width ≥ 65% of LVOT\n  * Vena contracta width of \\> 6 mm\n  * Holodiastolic flow reversal in proximal abdominal\u002Fdescending aorta\n  * Jet deceleration rate\u002FPressure half time \\\u003C200ms\n  * AND, For Grade 3:\n  * Regurgitant volume ≥ 45-59 ml\u002Fbeat\n  * Regurgitant fraction ≥ 40-49%\n  * EROA ≥ 0.2-0.29 cm2\n  * OR, For Grade 4:\n  * Regurgitant volume ≥ 60 ml\u002Fbeat\n  * Regurgitant fraction≥50%\n  * EROA ≥ 0.3 cm2 Note: In cases where not all criteria listed for severe AR are met, the Core Lab will determine severity. Supplemental CMR imaging may be used to substantiate the degree of AR reported by Core Lab on baseline echo when imaging is suboptimal, Doppler parameters are discordant or inconclusive regarding the severity of AR, or when a discrepancy is present between the echo findings and the clinical setting.\n* Patients who have symptoms obviously caused by Aortic Regurgitation, such as dyspnea, chest pain, NYHA Class II or higher;\n* Patients who are unsuitable for conventional surgery but needs TAVR（It is recommended to refer to the 2020 ACC\u002FAHA Heart Valve Disease Management Guidelines when evaluating the risks of surgical valve surgery），evaluated by the cardiac team (including at least one interventional cardiologist and one cardiovascular surgeon)\n* Patient has suitable anatomy to accommodate the insertion and delivery of the JenaValve Trilogy™ Heart Valve System，evaluated by core laboratory;\n\nExclusion Criteria:\n\n* Congenital uni- or bicuspid aortic valve morphology；\n* Previous prosthetic aortic valve (bioprosthesis or mechanical) implant；\n* Mitral regurgitation or Tricuspid regurgitation\\> moderate；\n* Clinically significant coronary artery disease (CAD) requiring revascularization within 30 days prior to index procedure, or planned CAD revascularization procedure within 12 months after index procedure；\n* Echocardiographic evidence of left ventricular thrombus；\n* Endocarditis within 180 days prior to index procedure；\n* Hypertrophic cardiomyopathy with or without obstruction；\n* Severe pulmonary hypertension (systolic PA pressure \\>80 mmHg)；\n* Severe RV dysfunction as assessed clinically and by echo；\n* Severely reduced left ventricular ejection fraction (LVEF \\\u003C25%)；\n* Aortic annular perimeter derived diameter of \\\u003C21.0 mm or \\> 28.6 mm or perimeter \\\u003C66.0 mm or \\>90 mm (assessed by Multi-Detector CT measurement)；\n* Aortic annulus angulation \\> 70° (assessed by Multi-Detector CT measurement)；\n* Straight length of ascending aorta of \\\u003C 55 mm；\n* Significant disease of ascending aorta, including ascending aortic aneurysm ； (defined as maximal luminal diameter of 50 mm or greater) or atheroma (including if thick \\[\\>5 mm\\], protruding or ulcerated)\n* Need for urgent or emergent TAVR procedure for any reason；\n* Cardiogenic shock or hemodynamic instability requiring inotropic support or ventricular assist device within 30 days prior to index procedure；\n* Myocardial infarction \\\u003C 30 days prior to index procedure；\n* Cerebrovascular event (TIA, stroke) \\\u003C 180 days prior to index procedure；\n* Patients with common carotid artery or internal carotid artery or vertebral artery stenosis (\\>70%)；\n* Patients with severe coagulopathy；\n* Severe renal insufficiency (GFR \\\u003C 30 ml\u002Fmin) at Screening, OR renal disease requiring renal replacement therapy within 180 days prior to index procedure；\n* Blood dyscrasias as defined: leukopenia (WBC \\\u003C 3000\u002Fmm³), or thrombocytopenia (platelets \\\u003C 90,000\u002Fµl) or anemia (Men: Hgb \\\u003C 8.1 g\u002Fdl; Women: Hgb \\\u003C 7.4 g\u002Fdl)；\n* Active peptic ulcer or upper gastrointestinal bleeding \\\u003C 90 days prior to index procedure；\n* Known allergies to to heparin, aspirin, ticlopidine, Clopidogrel, Nitroglycerin and other drugs，contrast agents, nitinol shape memory alloy, tantalum or porcine products；\n* Contraindication to intraoperative transesophageal echocardiography and\u002For Multi-Detector CT (MDCT) scan；\n* Estimated life-expectancy of \\\u003C 24 months；\n* Patient is enrolled in another investigational medical device or drug study which has not completed the required primary endpoint follow-up. (Note: Patients involved in a long-term surveillance phase of another study are eligible for enrollment in this study);\n* Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the patient from providing appropriate informed consent;\n* Severe dementia (resulting in either inability to provide informed consent for the trial\u002Fprocedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up assessments);\n* Unable to comply with follow-up requirements;",{"count":77,"type":20},116,[23],"To evaluate the safety and effectiveness of the TaurusTrio™ Heart Valve System in a patient population with symptomatic severe AR requiring replacement\u002Frepair of their native aortic valve that are at high risk for open surgical aortic valve replacement\u002Frepair (SAVR).",[81],"Aortic Regurgitation","2024-03-15",{"date":84,"type":36},"2024-03-18",{"date":86,"type":36},"2023-08-01",{"date":88,"type":20},"2029-07-31",{"name":42,"class":43},19,{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":21,"phases":100,"briefSummary":101,"conditions":102,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":44},"100486168","safety-and-efficacy-of-the-highlife-transcatherter-mitral-valve-replacement-system-in-patients-with-moderate-severe-or-severe-mitral-regurgitation-in-china-100486168","NCT05610566","Safety and Efficacy of the HighLife Transcatherter Mitral Valve Replacement System in Patients With Moderate-severe or Severe Mitral Regurgitation in China","A Prospective, Multicentric Clinical Trial Protocol to Evaluate the Safety and Efficacy of the HighLife Trans-Septal Transcatheter Mitral Valve Replacement System for the Treatment of Moderate-severe or Severe Mitral Regurgitation With Single-arm Objective Performance Criteria","Inclusion Criteria:\n\n1. Patients who voluntarily participate and sign the informed consent form and can cooperate with the completion of the entire trial process;\n2. Age ≥ 18 years old;\n3. Moderate-severe or severe mitral regurgitation (≥3+); Note 1: Patients with ischemic or non-ischemic heart disease induced symptomatic secondary mitral regurgitation as the primary cause must be treated for at least 1 month after optimal guideline medical therapy (GDMT). Echocardiography should be performed 3 months after cardiac resynchronization therapy and 1 month after coronary revascularization to assess the degree of regurgitation.\n\n   Note 2: For patients with primary mitral regurgitation, the multidisciplinary cardiac team of the research center needs to use a standard scoring system, considering multiple factors such as complications, frailty, and disability, ensuring the enrolled with a high risk of surgery.\n4. Patients with New York Heart Association (NYHA) functional ratings are Class II, III, or ambulatory Class IV;\n5. Anatomically appropriate for treatment with the HighLife Transcatheter Mitral Valve Replacement System.\n\nExclusion Criteria:\n\n1. Patients had any stroke\u002FTIA within 30 days;\n2. Patients with severe symptomatic bilateral carotid stenosis (\\>70% stenosis on non-invasive imaging);\n3. Patients with active infection requiring antibiotic therapy;\n4. Patients with active ulcer or gastrointestinal bleeding within the past 3 months;\n5. Patients with history of coagulopathy or refuse future blood transfusion;\n6. Patients unable to undergo transesophageal echocardiography (TEE);\n7. Patients who are pregnant or breastfeeding, or planning to have children within 12 months;\n8. Patients who are unable to adhere to the follow-up schedule and complete the examination;\n9. Patients enrolled in other clinical studies and within the follow-up period;\n10. Patients with known allergies to device components or contrast agents;\n11. Patients unable to receive anticoagulant or antiplatelet therapy;\n12. Patients with a life expectancy of less than 12 months due to non-cardiac disease;\n13. Patients requiring emergency surgical treatment;\n14. Patients scheduled for cardiac surgery within 12 months;\n15. Patients with an inappropriate mitral annulus or leaflet size (\\\u003C30 mm and \\>45 mm);\n16. Patients with moderate or above mitral stenosis;\n17. Flail mitral leaflets, or moderate to severe mitral valve prolapse;\n18. Patients with severe hepatic or renal insufficiency;\n19. Patients with severe calcification of the mitral annulus and\u002For mitral leaflets;\n20. Patients with history of mitral valve surgery or interventional therapy, or left atrial appendage occlusion device;\n21. Patients had acute myocardial infarction (MI) (Q-wave MI, or non-Q-wave MI, with CK-MB twice the normal and\u002For T-MB) within the past 1 month;\n22. Patients with untreated symptomatic coronary lesions requiring revascularization;\n23. Patients with untreated severe aortic stenosis and severe aortic regurgitation;\n24. Patients with aortic valve prosthesis;\n25. Patients with severe tricuspid valve lesions requiring surgical intervention;\n26. Patients with significant right ventricular dysfunction (such as biliteral lower extremities edema with increased jugular vein pulsation and hepatomegaly;\n27. LVEF \\\u003C 30%; LVEDD \\> 70 mm;\n28. Patients with echocardiographically confirmed intracardiac mass, thrombus or neoplasm;\n29. Hypertrophic obstructive cardiomyopathy (HOCM);\n30. Patients with active or recent (within 3 months) endocarditis;\n31. Patients with definite non-left heart disease induced severe pulmonary hypertension (echocardiographic indication: systolic pulmonary artery pressure (SPAP) \\> 70 mmHg)\n32. Patients with hypotension (systolic blood pressure \\\u003C90 mmHg) occurring within 7 days or mechanical hemodynamic support.",{"count":99,"type":20},110,[23],"To observe and evaluate the safety and efficacy of the HighLife Transcatheter Mitral Valve Replacement System in patients with moderate-severe or severe mitral valve regurgitation through a prospective, multicenter clinical trial using objective performance criteria.",[58],"2022-11-07",{"date":105,"type":36},"2022-11-09",{"date":107,"type":36},"2022-07-06",{"date":109,"type":20},"2029-07-06",{"name":42,"class":43},""]