[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636007":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":24,"locations":30,"responsibleParty":45,"collaborators":11,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":49,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":11,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":11,"overallStatus":67,"whyStopped":11,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"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,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Fuzhou","Fujian","China","CN",{"type":37,"coordinates":38},"Point",[39,40],119.30611,26.06139,{"lat":40,"lon":39},[43],{"name":21,"role":27,"phone":11,"phoneExt":11,"email":44},"chenliangwan@fjmu.edu.cn",{"type":46,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100636007","catheter-oriented-unloading-and-recovery-with-a-left-ventricular-assist-gear-efficacy-in-post-cardiotomy-cardiogenic-shock-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":59,"type":60},60,"ESTIMATED","INTERVENTIONAL",[63],"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.",[66],"Cardiogenic Shock","NOT_YET_RECRUITING","2026-05-06",{"date":70,"type":71},"2026-05-11","ACTUAL",{"date":73,"type":60},"2026-05",{"date":75,"type":60},"2027-06",{"name":5,"class":6},1]