Evaluation of the PulseCath, a Pulsatile Catheter Pump, in patients who need cardiac assist. - PulseCath 14 day study

PulseCath BV0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•Cardiac index (CI) < 2.2 L/min/m2, pre-PulseCath, despite appropriate inotropic support and/or IABP
•Mean arterial pressure (MAP) < 60 mmHg, pre-PulseCath, despite appropriate inotropic support and/or IABP
•Expected duration of support by the PulseCath: 24 hours to 14 days
•Patient older than 18 years
•Patient or legal representative has signed the Informed Consent

•Aortic disease: ascending aortic aneurism, severe calcified aorta
•Aortic valvular disease: aortic valve stenosis, aortic valve insufficiency
•Aortic valve prosthesis
•Subclavian artery stenosis in case of insertion via subclavian artery
•Thrombus in left ventricle
•No residual function of the left ventricle
•No functioning right ventricle
•History of coagulation disorders
•Previous history of CVA within the last 12 months
•Liver dysfunction, evidenced by: ALT > 100 U/L (men) > 70 U/L (women) or AST > 100 U/L (men) > 70 U/L (women)
•Patients with chronic renal failure requiring dialysis
•Participation in another clinical study that may interfere with this study

发起方

PulseCath BV