[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525914":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":30,"locations":35,"responsibleParty":67,"collaborators":24,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":24,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":24,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":24,"overallStatus":38,"whyStopped":24,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Fujian Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Interventional Left Ventricular Assist System Pre-trial","EXPERIMENTAL","The design of the first phase pre-trial clinical study will involve a total of 6 subjects. The survival rate of subjects before discharge or 30 days after weaning was the main effectiveness evaluation indicator, and the safety and effectiveness of the test device were preliminarily evaluated. All SAE events during the study will be reviewed by CEC experts. According to the expert review opinions, if no unexpected serious complications and product defects are found, the Formal Research phase will be started.",[13],"Device: Interventional Left Ventricular Assist System",{"label":15,"type":10,"description":16,"interventionNames":17},"Interventional Left Ventricular Assist System Formal Research","A formal clinical trial to evaluate the effectiveness and safety of interventional left ventricular assist system for hemodynamic support in patients with cardiogenic shock through a prospective, multicenter, single-group target value study.The total number of patients enrolled in this study is planned to be 54. This sample size is calculated according to statistical principles, combining the research hypothesis and the estimate of the expected level of efficacy. The sample size calculation is based on the main efficacy index and the main safety index. Since it is set according to the common evaluation index, the sample size is calculated for the two main evaluation indicators separately, and the largest one is used as the final sample size of this trial.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","Interventional Left Ventricular Assist System","Interventional left ventricular assist system for cardiogenic shock patients",[15,9],null,[26],{"name":27,"affiliation":28,"role":29},"Liang-wan Chen, M.D Ph.D","Fujian Medical University Union Hospital","STUDY_CHAIR",[31],{"name":27,"role":32,"phone":33,"phoneExt":24,"email":34},"CONTACT","+8613358255333","chenliangwan@tom.com",[36,59],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Department of Cardiovascular Surgery","RECRUITING","Fuzhou","Fujian","350001","China","CN",{"type":45,"coordinates":46},"Point",[47,48],119.30611,26.06139,{"lat":48,"lon":47},[51,55],{"name":52,"role":32,"phone":53,"phoneExt":24,"email":54},"Liang-Wan Chen, M.D, Ph.D","86 13358255333","daixiaofu719@hotmail.com",{"name":56,"role":32,"phone":57,"phoneExt":24,"email":58},"E Lin, M.D","86 13365912195","1470054258@qq.com",{"facility":28,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":60,"geoPoint":62,"contacts":63},{"type":45,"coordinates":61},[47,48],{"lat":48,"lon":47},[64],{"name":65,"role":32,"phone":66,"phoneExt":24,"email":34},"Liang-wan Chen, PhD MD","13358255333",{"type":68,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Liang-Wan Chen MD","Chief","100525914","an-interventional-left-ventricular-assist-system-for-cardiogenic-shock-100525914",false,"NCT06127927","An Interventional Left Ventricular Assist System for Cardiogenic Shock","Evaluation the Efficacy and Safety of an Interventional Left Ventricular Assist System for Hemodynamic Support in Patients With Cardiogenic Shock: A Prospective, Multicenter, Single-group Target Value Study of Sustained","For Pre-trial Phase\n\nInclusion Criteria:\n\n1. Age 18-75 years old;\n2. Refractory cardiogenic shock as determined by the cardiac MDT expert group; The criteria for refractory cardiogenic shock are: despite adequate doses of two vasoactive drugs and treatment of the underlying cause, there is still evidence of tissue hypoperfusion;\n3. The subject can understand the purpose of the trial, voluntarily participate and sign the written informed consent form reviewed and approved by the ethics committee; the subject agrees to complete the follow-up in accordance with the protocol requirements.\n\nExclusion Criteria:\n\n1. Right heart failure that meets any of the following conditions:\n\n   a Central venous pressure-capillary wedge pressure ≥10mmHg; b Central venous pressure-pulmonary artery diastolic pressure ≥10mmHg; c Cardiac tamponade.\n2. Any peripheral vascular disease that prevents the placement of the trial device;\n3. Left or right ventricular thrombus;\n4. Aortic valve regurgitation, echocardiographic grade ≥2+;\n5. Aortic valve stenosis, valve area ≤1.5cm2;\n6. Aortic valve calcification;\n7. Presence of mechanical aortic valve;\n8. Hypertrophic or obstructive cardiomyopathy;\n9. Untreated ventricular septal or atrial septal defect;\n10. Patent foramen ovale;\n11. Mechanical complications of acute myocardial infarction;\n12. Presence of hereditary spherocytosis, hereditary elliptocytosis, autoimmune hemolytic anemia or other diseases that cause hemolysis;\n13. Cardiopulmonary resuscitation lasting more than 15 minutes within 24 hours before catheter pump implantation;\n14. Ventricular tachycardia or ventricular fibrillation is ineffective with drug treatment;\n15. Renal failure, serum creatinine ≥309.4umol\u002Fl or blood urea nitrogen ★ ≥35.7mmol\u002Fl);\n16. Liver failure (total bilirubin ≥85.5umol\u002Fl);\n17. Allergy or intolerance to heparin;\n18. Presence of any cardiac assist device;\n19. Presence of active systemic infection;\n20. Refusing to sign the informed consent form or failing to complete follow-up as required by the protocol;\n21. Pregnant or lactating women, female subjects with potential fertility but unable or unwilling to use effective contraceptive measures during the study;\n22. Subjects who have participated in other clinical trials within 3 months or are currently participating in other clinical trials;\n23. Other situations that the investigator believes are not suitable for clinical trials.\n\nFor Formal Research Phase\n\nInclusion Criteria:\n\n1. Age 18-75 years old;\n2. Low cardiac output syndrome or increased filling pressure after regular continuous pumping of 1 high-dose or 2 medium-dose inotropic drugs within 48 hours after cardiopulmonary bypass was removed during cardiac surgery. The specific criteria are as follows;\n\nThe drugs, doses and time of 1 high-dose or 2 medium-dose inotropic drugs are as follows:\n\nEpinephrine: medium dose (\\\u003C0.03 μg\u002Fkg\u002Fmin), continuous pumping ≥15 minutes High dose (≥0.03 μg\u002Fkg\u002Fmin), continuous pumping ≥15 minutes; Dobutamine: medium dose (\\\u003C5μg\u002Fkg\u002Fmin), continuous pumping ≥15 minutes High dose (≥5μg\u002Fkg\u002Fmin), continuous pumping ≥15 minutes; Milrinone: medium dose (\\\u003C0.3 μg\u002Fkg\u002Fmin), continuous pumping ≥120 minutes High dose (≥0.3 μg\u002Fkg\u002Fmin), continuous pumping ≥120 minutes; Low cardiac output syndrome: cardiac index 1.3≤CI≤2.2 L\u002Fmin\u002Fm2;\n\nIncreased filling pressure: pulmonary capillary wedge pressure:\n\n20≤PCWP≤30mmHg or pulmonary artery systolic pressure: 25≤PAP≤35mmHg 3) The subject can understand the purpose of the trial, voluntarily participate and sign the informed consent form reviewed and approved by the ethics committee; the subject agrees to complete the follow-up in accordance with the protocol requirements.\n\nExclusion Criteria:\n\n1. Right heart failure that meets any of the following conditions:\n\n   1. Central venous pressure-capillary wedge pressure ≥10mmHg;\n   2. Central venous pressure-pulmonary artery diastolic pressure ≥10mmHg;\n   3. Cardiac ascites.\n2. Any peripheral vascular disease that prevents the placement of the trial device;\n3. Left or right ventricular thrombus;\n4. Aortic valve regurgitation, echocardiographic grade ≥2+;\n5. Aortic valve stenosis, valve area ≤1.5cm2;\n6. Presence of mechanical aortic valve;\n7. Hypertrophic or obstructive cardiomyopathy;\n8. Untreated ventricular septal or atrial septal defect;\n9. Patent foramen ovale;\n10. Mechanical complications of acute myocardial infarction;\n11. Suffering from diseases that cause increased blood cell fragility or hemolysis;\n12. Cardiopulmonary resuscitation lasting more than 15 minutes within 24 hours before catheter pump implantation;\n13. Sustained or non-sustained ventricular tachycardia or ventricular fibrillation that is unresponsive to drug treatment;\n14. Renal failure, serum creatinine ≥3.5mg\u002Fdl or blood urea nitrogen ≥100mg\u002Fdl;\n15. Liver failure, total bilirubin ≥5mg\u002Fdl;\n16. Allergy or intolerance to heparin;\n17. Other cardiac assist devices other than IABP have been implanted;\n18. Active systemic infection;\n19. Refuse to sign the informed consent form or fail to complete follow-up as required by the protocol;\n20. Pregnant or lactating women, female subjects with potential fertility but unable or unwilling to use effective contraceptive measures during the study;\n21. Subjects who are participating in other clinical trials and have not yet reached the endpoints of the trial;\n22. Other situations that the investigator believes are not suitable for clinical trials.","ALL","18 Years","75 Years",{"count":82,"type":83},60,"ESTIMATED","INTERVENTIONAL",[86],"NA","Imported Impella The price is relatively expensive and difficult for ordinary patients to afford. In order to better meet the growing clinical needs in China, Anhui Tongling Bionic Technology Co., Ltd. has developed an interventional left ventricular assist system. The test device was tested in preclinical animals It has shown good effectiveness and safety. Through the implementation of this clinical trial, the interventional left ventricular assist system The safety and effectiveness of the system for hemodynamic support in patients with cardiogenic shock have led to further development of this product in the country.",[89],"Cardiogenic Shock","2024-07-04",{"date":92,"type":93},"2024-07-08","ACTUAL",{"date":95,"type":93},"2023-11-08",{"date":97,"type":83},"2025-12-08",{"name":5,"class":6},2]