[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100447442":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":37,"responsibleParty":67,"collaborators":31,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":31,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":92,"overallStatus":94,"whyStopped":31,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},{"fullName":5,"class":6},"Fresenius Medical Care Deutschland GmbH","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"venoarterial extracorporeal membrane oxygenation (VA ECMO) for cardiocirculatory stabilization","OTHER","Patients with cardiogenic shock, requiring a venoarterial extracorporeal membrane oxygenation (VA ECMO) for cardiocirculatory stabilization will be treated with Synchronized Cardiac Support (SCS).",[13],"Device: Synchronized Cardiac Support with the icor kit",[15],{"type":16,"name":17,"description":11,"armGroupLabels":18,"otherNames":19},"DEVICE","Synchronized Cardiac Support with the icor kit",[9],[20],"Synchronized Cardiac Support (icor)",[22],{"name":23,"affiliation":24,"role":25},"Ingo Voigt, Dr.","Elisabeth-Krankenhaus Essen","PRINCIPAL_INVESTIGATOR",[27,33],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Anja Derlet-Savoia, Dr.","CONTACT","+49 6172 2686648",null,"anja.derlet@freseniusmedicalcare.com",{"name":34,"role":29,"phone":35,"phoneExt":31,"email":36},"Celina Erfle","+49 6172 2686809","celina.erfle@freseniusmedicalcare.com",[38,54],{"facility":39,"status":31,"city":40,"state":31,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Krankenhaus Buchholz und Winsen gGmbH","Buchholz","21244","Germany","DE",{"type":45,"coordinates":46},"Point",[47,48],9.56119,53.01126,{"lat":48,"lon":47},[51],{"name":52,"role":29,"phone":31,"phoneExt":31,"email":53},"Hertting Klaus, Dr med","Klaus.Hertting@krankenhaus-buchholz.de",{"facility":55,"status":31,"city":56,"state":31,"zip":57,"country":42,"countryCode":43,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Elisabeth-Krankenhaus Essen GmbH","Essen","45138",{"type":45,"coordinates":59},[60,61],7.01228,51.45657,{"lat":61,"lon":60},[64],{"name":65,"role":29,"phone":31,"phoneExt":31,"email":66},"Voigt Ingo, Dr med","I.Voigt@contilia.de",{"type":68,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100447442","efficacy-and-safety-of-synchronized-cardiac-support-in-cardiogenic-shock-patients-100447442",false,"NCT05106491","Efficacy and Safety of Synchronized Cardiac Support in Cardiogenic Shock Patients","Evaluating the Efficacy and Safety of the Synchronized Cardiac Support Treatment with the Icor Kit in Patients with Cardiogenic Shock - a Pivotal Study (Pulse SE)","PulseSE","Inclusion Criteria:\n\n1. Informed consent signed and dated by study patient\u002Flegal representative and investigator\u002Fauthorised physician\n2. Minimum age of 18 years\n3. Patients in cardiogenic shock\n4. Cardiogenic shock is defined as:\n\n   1. Systolic blood pressure \\\u003C 90 mmHg for at least 30 min\n   2. Inotropes and\u002For vasopressors are needed to maintain systolic blood pressure \\> 90 mmHg\n   3. Clinical signs of heart insufficiency with pulmonary congestion\n5. Signs of end organ hypoperfusion with at least one of the following criteria:\n\n   1. Cold, damp skin or extremities\n   2. Oliguria (≤ 30 mL\u002Fh)\n6. Serum lactate \\> 3.0 mmol\u002FL\n\nExclusion Criteria:\n\n1. In case of female patients: pregnancy or lactation period\n2. Participation in an interventional clinical study during the preceding 30 days\n3. Previous participation in the same study\n4. Age \\> 85 years\n5. Cardiac arrest out of hospital with return of spontaneous circulation (ROSC) \\> 30 min\n6. No flow time \\> 5 min\n7. Mechanical causes for cardiogenic shock (ventricular septal defect of papillary muscle rupture)\n8. Non-cardiogenic causes of shock (bradycardia, sepsis, hypovolemia, etc.)\n9. Fever (Body temperature \\> 38.0 °C) or other evidence of sepsis\n10. Onset of cardiogenic shock \\> 6 h before enrolment\n11. Lactate \\> 16 mmol\u002FL\n12. Severe peripheral arterial occlusive disease precluding insertion of femoral arterial or venous catheters\n13. Contra-indications for anticoagulation\n14. Contra-indication for VA ECMO, e.g. unrecoverable heart and not a candidate for transplant or VAD","ALL","18 Years","85 Years",{"count":81,"type":82},21,"ESTIMATED","INTERVENTIONAL",[85],"NA","The study aims to investigate the safety and efficacy of the Synchronized Cardiac Support treatment wit the icor kit and the Xenios console with modified sensor box ECG and Software Version 3.2.4",[88,89,90,91],"Cardiogenic Shock","Extracorporeal Membrane Oxygenation","ECLS","VA ECMO",[88,89,93,90,91],"Synchronized Cardiac Support","NOT_YET_RECRUITING","2025-03-13",{"date":97,"type":98},"2025-03-14","ACTUAL",{"date":100,"type":82},"2025-09",{"date":102,"type":82},"2026-09",{"name":104,"class":6},"Xenios AG",2]