A prospective, Phase 1, open treatment, non comparative, single centre, device study to evaluate the safety and performance of the MTMM bi-directional cannula in patients undergoing VA-ECMO support.

The Alfred Hospital0 个研究点目标入组 15 人开始时间: 2015年10月15日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•1.Must be between18 years and 80 years inclusive.
•2. Assessed as requiring V-A ECMO support by ICU consultant
•3. Must weigh between 45kg and 130kg inclusive.
•4. Site personel must obtain written informed consent from the patient or their legally authorised representative prior to any study procedures

•Patients with a history of peripheral vascular disease
•-previous peripheral arterial bypass
•-diabetic vasculopathy
•2. Patients with a history of diabetic retinopathy
•3. Patients with a history of diabetic nephropathy
•4. Patients where the common femoral artery is not identifiable with vascular ultrasound.
•5. Patients where the common femoral artery is identifiable with vascular ultrasound but the internal diameter of the femoral artery is not greater than 0.6cm.
•6.Patients requiring ECMO support to be instituted in the emergency setting during Cardio Pulmonary Resuscitation (CPR).
•7. Non Alfred Hospital VA ECMO initiation (retrieval)
•8. Concurrent enrolment in another investigational drug or device study, or use of any experimental or investigational drug or device within 30 days of ECMO support.
•9. Any other medical condition which in the view of the investigator is likely to interfere with the study or put the participant at risk.
•10. Patients who the investigator feels may not achieve adequate flow rates and line pressures due to their weight or body height.

发起方

The Alfred Hospital