Refractory end-stage or advanced heart failure
Conditions
Interventions
Case series:implantable left ventricular assist system CH-VAD
Sponsors
Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Age =18; 2)Subject or legal representative has signed Informed Consent Form (ICF) 3)Body Surface Area (BSA) = 1.2 m2. 4)Females of child bearing age must agree to use adequate contraception. 5)Left ventricular ejection fraction (LVEF) = 30%. 6)Patients with NYHA Class IV heart failure symptoms who are failing to reverse the disease course by oral medication. 7)Meet at least one of the following: ?Hemodynamically stable but Inotrope dependent; ?Temporary cardiac assistance device cannot be removed, such as intra-aortic balloon pump (IABP) or Extracorporeal Membrane Oxygenator(ECMO); ?Cardiogenic shock.
Exclusion criteria
Exclusion criteria: 1) Etiology of heart failure (HF) due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis or restrictive cardiomyopathy. 2) Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator. 3) Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the patients' health status. 4) Planned Bi-VAD support prior to enrollment. 5) Pregnancy. 6) Presence of mechanical aortic valve. 7) Moderate to severe aortic insufficiency without plans for correction during pump implantation surgery. 8) History of visceral organ transplant. 9) Uncorrected thrombocytopenia (platelet count 2.0 in the absence of anticoagulation therapy), disseminated intravascular coagulation . 10) Temperature > 38.5 (°C) and white blood cell count > 10×109/L, neutrophil count proportion>85% within 24 hours prior to surgery 11) Serum total bilirubin>3.0mg/dL within 48 hours prior to surgery. 12) Serum creatinine > 3.0 mg/dL within 48 hours prior to surgery. 13) History of severe COPD or restrictive lung disease. 14) Primary pulmonary hypertension. 15) History of pulmonary embolism within 3 weeks prior to enrollment. 16) History of stroke within 90 days prior to surgery. 17) History of confirmed, untreated abdominal or thoracic aortic aneurysm > 5 cm. 18) Patients with severe aortic atherosclerotic plaques. 19) Albumin < 30g/L, or/ and Pre albumin < 150 mg/L within 48 hours prior to surgery. 20) Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAS management. 21) Any malignant tumor or other disease that could limit survival to less than 1 year. 22) Participation in any other clinical investigation that is likely to confound study results or affect the study. 23) Unforeseen, inappropriate situation in the judgment of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Short Term Survival (3 months); | — |
Countries
China
Contacts
Public ContactHaibo Chen
Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)
Outcome results
None listed