[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"va-ecmo\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:va-ecmo":56},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,39],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":5},"100594455","comparing-a-suture-based-system-for-the-removal-of-arterial-and-veinous-ecmo-cannulas-to-the-standard-approach-100594455",false,"NCT07019662","Comparing a Suture-based System for the Removal of Arterial and Veinous ECMO Cannulas to the Standard Approach","CLOSE-ECMO","Inclusion Criteria:\n\n* Age ≥ 18 Years\n* Femoral placement of VA-ECMO with peripheral, percutaneous cannulation\n* Arterial puncture site above the femoral bifurcation\n* Cannula size must match or be smaller than the maximally licensed diameter for Perclose™ ProStyle™ (26 F (French) outer diameter arterial and 29 F outer diameter veinous)\n* Patients must be eligible for either the Perclose™ ProStyle™ device or one of the two guideline-compliant alternatives for ECMO cannula removal (manual compression or surgical closure) according to the investigator's judgment.\n* Initial arterial and\u002For venous puncture for ECMO cannulation was performed using ultrasound guidance with corresponding documentation available in the patient record.\n\nExclusion Criteria:\n\n* Severe calcification\n* Surgical cannulation\n* Ongoing Infection of the ECMO site\n* Any patient who does not fullfil the eligibility criteria for the use of the study device according to its current Instructions for Use (IFU), including known contraindications, limitations or warnings.\n* Participation in another interventional clinical trial.\n* Patients who are pregnant (assessed by clinical routine testing) or lactating.","ALL","18 Years",{"count":19,"type":20},102,"ESTIMATED","INTERVENTIONAL",[23],"NA","Background:\n\nPatients with severe heart and lung failure may be treated with VA-ECMO (veno-arterial extracorporeal membrane oxygenation), a life-support machine that temporarily takes over the function of the heart and lungs. To connect the patient to ECMO, large tubes (cannulas) are inserted into major blood vessels in the groin area.\n\nWhen the patient no longer needs ECMO, these cannulas must be removed - a process known as decannulation. Closing the artery after removing the cannula is a critical step and can be associated with complications such as bleeding, vessel injury, or blood clots.\n\nCurrently, there are different methods to close the artery:\n\n* Surgical closure: open surgery to directly suture the artery\n* Manual compression: pressing on the artery to stop bleeding\n* Vascular closure devices (VCDs): special tools that close the artery through the skin\n\nThere is no clear standard yet on which method is safest and most effective for ECMO patients.\n\nPurpose of the Study:\n\nThe study aims to determine whether using a vascular closure device is as safe and effective as the current standard methods for femoral artery closure after VA-ECMO.\n\nStudy Design:\n\nThis is a randomized controlled trial. Patients who are scheduled for decannulation after VA-ECMO support will be randomly assigned to one of two groups:\n\n* Intervention Group: Patients receive a vascular closure device to seal the artery (Abbott Perclose™ ProStyle™ Suture-Mediated Closure System).\n* Control Group: Patients receive standard care, which may be either:\n\n  * Manual compression, or\n  * Surgical closure, depending on the treating physician's judgment and the patient's condition.\n\nThis allows for a real-world comparison of the Closure Device method to current clinical practice.",[26],"VA-ECMO","RECRUITING","2026-04-15",{"date":30,"type":31},"2026-04-16","ACTUAL",{"date":33,"type":31},"2025-10-27",{"date":35,"type":20},"2027-09",{"name":37,"class":38},"IHF GmbH - Institut für Herzinfarktforschung","OTHER",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":57,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":5},"100447442","efficacy-and-safety-of-synchronized-cardiac-support-in-cardiogenic-shock-patients-100447442","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","85 Years",{"count":49,"type":20},21,[23],"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",[53,54,55,56],"Cardiogenic Shock","Extracorporeal Membrane Oxygenation","ECLS","VA ECMO",[53,54,58,55,56],"Synchronized Cardiac Support","NOT_YET_RECRUITING","2025-03-13",{"date":62,"type":31},"2025-03-14",{"date":64,"type":20},"2025-09",{"date":66,"type":20},"2026-09",{"name":68,"class":69},"Xenios AG","INDUSTRY"]