acute decompensated heart failure (ADHF), cardiorenal syndrome (CRS) I50.9 I42.0 I11 I25
Conditions
Interventions
Group 1: Acute Decompensated Heart Failure (ADHF) patients with impaired kidney function will be treated für 24 hours with the 10F-Reitan Catherer Pump (10F-RCP). The 10F-RCP is percutaneous mechanica
Sponsors
Cardiobridge GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: EF < 30%; Cardiac index < 2.2 l/min/m2; Informed consent; Age between 18- 75 years old; eGFR (MDRD) between 15 - 50 ml/min/1.73m²
Exclusion criteria
Exclusion criteria: 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; Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in eGFR (based on MDRD formula) during 24 hours (Day 1) treatment with the 10F-RCP compared to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 10F-RCP treatment induced changes in the following parameters: PCWP, CVP, PAP, MAP, CI, CO after a treatment duration of 24h compared to baseline data; 10F-RCP treatment induced changes in the following parameters: eGFR, SCr, Cystatin C, NT-proBNP during treatment (Day 1) and after treatment at Day 2, Day 3, Day 5 and Day 7 (or earlier if patient will be discharged or switched to another device therapy) compared to baseline data; 10F-RCP treatment induced changes in the following parameters: Lactate, AST/ALT, Troponine T, CKMB, CK, Myoglobine, LDH, Fibrinogene, and Urine Output during treatment (Day 1) and after treatment and additionally at Day 2 for Lactate and LDH. INTERMACS level changes at baseline compared to 24 hours of treatment (Day 1), Day 2 and Day 7* (or earlier if patient will be discharged or switched to another device therapy); Adverse Events (as risk-assessment): Major Bleeding; Hemolysis; Device Malfunction; Limb ischemia; Need for transfusion; thrombo-embolic complication; Neurologic complication. | — |
Countries
Germany
Contacts
Public ContactKarim El Banayosy
Cardiobridge GmbH
Outcome results
None listed