Post-approval trial to evaluate the performance of the 10F-Reitan Catheter Pump in advanced heart failure patients - RCPerformance

Cardiobridge GmbH0 个研究点目标入组 20 人开始时间: 2019年4月1日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Renal Replacement Therapy (RRT);
•Isolated Right Heart Failure, CVP =25 mmHg;
•Cardiogenic shock due to acute coronary syndrome (ACS);
•Restrictive Cardiomyopathy;
•Hypertrophic Cardiomyopathy;
•Heparin-Induced Thrombocytopenia (HIT);
•Pulmonary vascular hypertension with PCWP < 15 mm Hg;
•Systolic pressure less than 75 mm Hg for 30 mins;
•Septic Shock;
•Tortuous iliac arteries (Anatomical variations) OR Inability to gain access for introducer sheath or catheterization;
•Severe Peripheral arterial disease (PAD);
•Aortic diseases: Previous intravascular repair/stenting of aorta/femoral arteries, Aortic dissection chronic or acute, known aortic aneurysm, known severe calcified aorta-iliac disease or peripheral vascular disease;
•Descending thoracic aortic diameter < 21 mm;
•Aortic or mitral valve stenosis (II or greater);
•Known coagulopathy ;
•Known thrombocytopenia or platelet dysfunction;
•Significant blood dyscrasia, which is defined as any hematologic disorder characterized by intravascular hemolysis or associated with increased fragility of the red blood cell;
•Lack of patient co-operation or no informed consent;

发起方

Cardiobridge GmbH