None listed
Conditions
Brief summary
This multi-center, prospective, non-randomized, single-arm trial will investigate the safety and performance of the HeartWare 'Registered Trademark' Miniaturized Ventricular Assist Device (MVAD 'Registered Trademark' Pump) system over 24 months in subjects with advanced heart failure
Interventions
Implants of the MVAD’Registered Trademark’ pump may be performed via a median sternotomy or lateral thoracotomy. In all cases a cardiopulmonary bypass is required. An expert from HeartWare will be present during surgery. During implantation, the pump’s integrated inflow cannula is inserted into the left ventricle and is secured to the myocardium using an adjustable sewing ring. A 10mm diameter, gel impregnated, polyester outflow graft connects the pump to a major artery. A strain relief fits ove
Implants of the MVAD’Registered Trademark’ pump may be performed via a median sternotomy or lateral thoracotomy. In all cases a cardiopulmonary bypass is required. An expert from HeartWare will be present during surgery. During implantation, the pump’s integrated inflow cannula is inserted into the left ventricle and is secured to the myocardium using an adjustable sewing ring. A 10mm diameter, gel impregnated, polyester outflow graft connects the pump to a major artery. A strain relief fits over the outflow graft to prevent kinking and to secure the outflow graft to the pump housing. The percutaneous driveline connects the implanted pump to the Pal 'Trademark' Controller and power sources. The driveline is wrapped with a woven polyester fabric to encourage tissue in-growth at the skin exit site. The pump size and intraventricular inflow cannula allow for pericardial placement, eliminating the need for an abdominal pocket. Implant procedure goes between 2-4 hours. Time in situ is difficult to determine as this depends on patient condition and may vary until clinical indicated explanation is required, the patient can receive a heart transplant or it can be even indefinitely.
Sponsors
HeartWare Inc.
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Must be greater than or equal to18 years of age at consent 2. Subjects with advanced heart failure symptoms (Class IIIB or IV) who meet one of the following): a. on optimal medical management including dietary salt restriction and diuretics, for at least 45 out of the last 60 days and are failing to respond; or b. in Class III or Class IV heart failure for at least 14 days and dependent on intra-aortic balloon pump (IABP) and/or inotropes. 3. Left ventricular ejection fraction less than or equal to 25%. 4. Female subjects of childbearing potential must agree to use adequate contraceptive precautions (defined as oral contraceptives, intrauterine devices, surgical contraceptives or a combination of condom and spermicide) for the duration of the study. 5. The subject has signed the informed consent form.
Exclusion criteria
1. Body Mass Index (BMI) > 47. 2. Body Surface Area (BSA) < 1.0 m2. 3. Partial or full mechanical circulatory support within thirty days of implant. 4. Existence of any ongoing mechanical circulatory support (MCS) other than an intra-aortic balloon pump (IABP) or TandemHeart PTVA 'Registered Trademark'. 5. Prior cardiac transplant or cardiomyoplasty. 6. History of confirmed, untreated abdominal or thoracic aortic aneurysm (diameter > 5 cm). 7. Acute myocardial infarction within 14 days of implant as diagnosed by ST or T wave changes on the electrocardiogram (ECG), diagnostic biomarkers, ongoing pain and hemodynamic abnormalities. 8. On ventilator support for > 72 hours within the four days immediately prior to implant. 9. Pulmonary embolus within three weeks of implant as documented by computed tomography (CT) scan or nuclear scan. 10. Symptomatic cerebrovascular disease, stroke within 180 days of implant or > 80% stenosis of carotid or cranial vessels in the absence of confirmed collateral circulation 11. Uncorrected moderate to severe aortic insufficiency. 12. Severe right ventricular failure as defined by the anticipated need for extracorporeal membrane oxygenation (ECMO) at the time of screening. 13. Active, uncontrolled infection diagnosed by a combination of clinical symptoms and laboratory testing, including but not limited to, continued positive cultures, elevated temperature and white blood cell (WBC) count, hypotension, tachycardia, generalized malaise despite appropriate antibiotic, antiviral or antifungal treatment. 14. Uncorrected thrombocytopenia or generalized coagulopathy (e.g., platelet count < 75,000, International Normalized Ratio (INR) > 2.0 or Partial Thromboplastin Time (PTT) > 2.5 times control in the absence of anticoagulation therapy). 15. Intolerance to anticoagulant or antiplatelet therapies or any other peri- or postoperative therapy that the investigator may administer based upon the subject’s health status. 16. Serum creatinine > 3.0 mg/dL within 72 hours of implant or requiring dialysis. 17. Specific liver enzymes [Aspartate Aminotransferase (AST) (SGOT), and Alanine Aminotransferase (ALT) (SGPT)] > 3 times upper limit of normal within 72 hours of implant. 18. A total bilirubin > 3 mg/dL within 72 hours of implant, or biopsy proven liver cirrhosis or portal hypertension. 19. Pulmonary vascular resistance (PVR) is demonstrated to be unresponsive to pharmacological manipulation. 20. Subjects with a mechanical heart valve. 21. Etiology of heart failure is due to, or associated with, uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, active myocarditis or restrictive cardiomyopathy. 22. History of severe COPD or severe restrictive lung disease (e.g. FEV1 < 50% predicted value). 23. Participation in any other trial involving investigational drugs or devices within 4 weeks prior to screening and last visit of the trial. 24. Severe illness, other than heart disease, which would limit survival to < 3 years. 25. Peripheral vascular disease with rest pain or ischemic ulcers of the extremities. 26. Pregnancy and breast feeding. 27. Psychiatric disease, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the CIP and LVAD. 28. Subject unwilling or unable to comply with trial requirements. 29. Technical obstacles, which pose an inordinately high surgical risk, in the judgment of the investigator. 30. Employees of the investigator or trial site, with direct involvement in this trial or other trials under the direction of the investigator or trial site, as well as family members or employees of the investigator.
Outcome results
None listed