[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636007":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":24,"locations":30,"responsibleParty":44,"collaborators":11,"id":46,"slug":11,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":47,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":11,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":11,"overallStatus":65,"whyStopped":11,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"ForQaly Medical (Shanghai) Co., Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SynFlow Duro","EXPERIMENTAL",null,[13],"Device: SynFlow Duro",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DEVICE","a novel micro-axial flow pump for temporary left ventricular assistance",[9],[20],{"name":21,"affiliation":22,"role":23},"Liangwan Chen","Fujian Medical University Union Hospital","STUDY_CHAIR",[25],{"name":26,"role":27,"phone":28,"phoneExt":11,"email":29},"Chen Jiang","CONTACT","+86 13918357410","cjiang@forqaly.com",[31],{"facility":22,"status":11,"city":32,"state":33,"zip":11,"country":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Fuzhou","Fujian","China",{"type":36,"coordinates":37},"Point",[38,39],119.30611,26.06139,{"lat":39,"lon":38},[42],{"name":21,"role":27,"phone":11,"phoneExt":11,"email":43},"chenliangwan@fjmu.edu.cn",{"type":45,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100636007",false,"NCT07560085","Catheter-Oriented Unloading and Recovery With a Left Ventricular Assist Gear: Efficacy in Post Cardiotomy Cardiogenic Shock","Efficacy and Safety of SynFlow Duro System in the Treatment of Post Cardiotomy Cardiogenic Shock: a Prospective, Multicenter, Single-arm Clinical Trial","COURAGE","Inclusion Criteria:\n\n* 18≤Age≤80, any sex.\n* Failure to wean from CPB or refractory cardiogenic shock after cardiac surgery.\n\nFailure to wean from CPB is defined as failed to discontinue CPB or post-weaning CI \\\u003C2.2L\u002Fmin\u002Fm2 + PCWP \\>15mmHg, despite optimal pre-weaning management and receiving at least one high dose inotrope.\n\nRefractory cardiogenic shock is defined as a condition that occurs despite adequate fluid status and meets all the following criteria:\n\n① CI\\\u003C2.2L\u002Fmin\u002Fm2 + PCWP\\>15mmHg despite receiving at least one high dose inotrope or IABP; OR SBP \\\u003C80mmHg or MAP\\\u003C50mmHg despite receiving at least one high dose intrope + high dose norepinephrine or IABP.\n\n② Presence of at least one signs indicating hypoperfusion: decreased mentation; cold, clammy, ashen or cyanotic extremities or skin or livedo reticularis; urine output\\\u003C30ml\u002Fh or 0.5ml\u002Fkg\u002Fh; or lactate\\>2mmol\u002FL or metabolic acidosis.\n\n\\- Patient has signed the informed consent form.\n\nExclusion Criteria:\n\n* Body surface area\\>2.5m2.\n* Presence of any cardiac assist device (other than an IABP).\n* Right ventricular failure.\n* Evidence of any vascular disease or anatomy precluding placement or deployment of the device (e.g. severely calcified vessel).\n* Evidence of ventricular thrombus.\n* Moderate or severe aortic valve insufficiency\u002Fstenosis, or severe aortic valve calcification.\n* Presence of mechanical aortic valve or cardiac contractile device.\n* Obstructive, hypertrophic cardiomyopathy.\n* Presence of uncorrected ventricular septal defect, atrial septal defect or patent foramen ovale.\n* Mechanical manifestation of AMI (e.g. ventricular septal rupture, papillary muscle rupture, ventricular rupture).\n* Any hematological disorder causing fragility of blood vessel or hemolysis.\n* Known allergy or intolerant to heparin.\n* Presence or suspicion of active systemic infection.\n* Cardiopulmonary resuscitative maneuver lasting longer than 20 minutes before device placement.\n* Sustained or non-sustained ventricular tachycardia or ventricular fibrillation unresponsive to medical therapy.\n* Severe hepatic dysfunction, renal failure or severe respiratory failure\n* Pregnant or lactating female.\n* Concomitant enrollment in another investigational drug or device study where the primary endpoint has not yet been completed or that will clinically interfere with the endpoint of this investigation.\n* Other conditions considered unsuitable for participating in this investigation by the investigators.","ALL","18 Years","80 Years",{"count":57,"type":58},60,"ESTIMATED","INTERVENTIONAL",[61],"NA","This study is a prospective, multicenter, single-arm clinical trial conducted in China to evaluate the efficacy and safety of a novel left ventricular assist device, SynFlow Duro system, manufactured by ForQaly Medical in the treatment of post cardiotomy cardiogenic shock.",[64],"Cardiogenic Shock","NOT_YET_RECRUITING","2026-05-06",{"date":68,"type":69},"2026-05-11","ACTUAL",{"date":71,"type":58},"2026-05",{"date":73,"type":58},"2027-06",{"name":5,"class":6},1]