[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"ForQaly Medical (Shanghai) Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":41},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"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":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28],"Cardiogenic Shock","NOT_YET_RECRUITING","2026-05-06",{"date":32,"type":33},"2026-05-11","ACTUAL",{"date":35,"type":22},"2026-05",{"date":37,"type":22},"2027-06",{"name":39,"class":40},"ForQaly Medical (Shanghai) Co., Ltd","INDUSTRY",""]