End-stage heart failure
Conditions
Interventions
Trail group:Implant trial device by operation
Sponsors
Teda International Cardiovascular Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with clinical diagnosis of end-stage heart failure, severe heart failure, cardiogenic shock, chronic episodes of chronic heart failure, and subjects with severe heart failure symptoms (in line with the New York Heart Association's NYHA ? Heart Function Grade IV) See the attachment for the evaluation criteria; 2. Body surface area (BSA) >= 1.2m2; 3. Aged >= 18 years, regardless of gender; 4. Meet any 5 or more of the following criteria: (1) Cardiac output index 5000ng / mL; (4) Estimated survival period 20mmHg; (7) It is difficult to maintain the circulatory function under high-dose vasoactive drugs (continuous infusion of at least one high-dose positive inotropic drug for intravenous injection: dobutamine >= 7.5 mcg / kg / min, milrinone >= 0.50 mcg / kg / min, epinephrine >= 0.02 mcg / kg / min; continuous infusion of at least two intravenous inotropic drugs: dobutamine >= 3 mcg / kg / min, milrinone >= 0.25 mcg / kg / min, epinephrine >= 0.01 mcg / kg / min, dopamine >= 3 mcg / kg / min); (8) mixed venous blood oxygen saturation <65%; (9) 6 minutes walking test <150 m; 5. Voluntarily participated in this clinical trial and signed written informed consent; 6. Women of childbearing age must agree to use appropriate contraception.
Exclusion criteria
Exclusion criteria: 1. Can not tolerate surgery and anticoagulant treatment. 2. There are valve implants and organ transplants (except corneal transplants). 3. Acute myocardial infarction occurred within 14 days before admission. 4. Patients receiving mechanical circulation support (except IABP). 5. Uncorrected thrombocytopenia or primary coagulation dysfunction (e.g., platelet count 1.6 or PTT > 2.5 times control without anticoagulant therapy). 6. Severe right ventricular failure is defined as a screening/into the group expected to right ventricular assist device (RVAD) support or extracorporeal membrane oxygenation (ECMO) or use a variety of positive inotropic drugs > 20 mmHg right atrial pressure, right ventricular ejection fraction (RVEF) 80%) within 90 days prior to enrollment. 8. Complicated with a confirmed, untreated abdominal aortic aneurysm or thoracic aortic aneurysm (>5 cm in diameter) or severe atherosclerosis. 9. With uncontrolled infection: positive diagnosed by clinical symptoms and laboratory tests, infection control, including but not limited to, although the appropriate antibiotic, antiviral and antifungal treatment, still appear continuous positive culture, high temperature ( > 37.5 degree C) and white blood cell count (WBC count > 10 x 10^9), low blood pressure, tachycardia, whole body discomfort of the patients. 10. Pulmonary embolism in the first three weeks after enrollment with severe chronic obstructive pulmonary disease (COPD, FEV1/FVC 3 mg/dL of total bilirubin, or biopsy confirmed cirrhosis or portal hypertension, within 24 hours after admission. Serum creatinine was 3.0 times higher than normal within 48 hours of enrollment or dialysis was required (excluding the use of ultrafiltration to remove body fluids). 12. Moderate to severe aortic insufficiency, with no plan to repair during pump implantation. 13. Heart failure due to or associated with thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, or restrictive cardiomyopathy. 14. Pulmonary artery systolic blood pressure over 60 mmHg combined with any of the following two variables proved that pulmonary vascular resistance did not respond to pharmacological treatment: pulmonary vascular resistance >5 Woods Units, cross-pulmonary pressure >= 16 mmHg. 15. Aortic, mitral, tricuspid or pulmonary valve replacement (including biological valves) or left ventricular (LV) aneurysm resection is required. 16. Prealbumin < 150 mg/L (15 mg/dL) or albumin < 30 g/L (3 g/dL) if only one is available; Prealbumin < 150 mg/L (15 mg/dL) and albumin < 30 g/L (3 g/dL) (if both are available). 17. Women who are breast-feeding, pregnant or planning to have children recently. 18. Patients complicated with mental illness, psychological problems or cognitive dysfunction and unable to cooperate with treatment. 19. Participate in other trials involving investigational drugs or devices within the last three months. 20. Patients unable to obtain the assistance of a cohabiting caregiver. 21. Patients un
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival rates; | — |
Secondary
| Measure | Time frame |
|---|---|
| NYHA grading;6 minutes walk distance test;NT-proBNP/BNP;Quality of Life;Nervous system state score;TTE;Equipment failure rate;Adverse event rate; | — |
Countries
China
Contacts
Public ContactXiaocheng Liu
Outcome results
None listed