Clinical Evaluation of HW005 Ventricular Assist System for the Treatment of Advanced Heart Failure in Japan

Clinical Evaluation of the HW005 Ventricular Assist System for the Treatment of Advanced Heart Failure

The purpose of the study is to evaluate the safety and effectiveness of the HW005 System in patients listed for cardiac transplantation with refractory, advanced heart failure at risk of death.

The primary endpoint is success at 180 days which is expressed as a simple proportion and defined as alive on the originally implanted HW005 or transplanted or explanted for recovery. Patients must survive 60 days post-explant for recovery to be considered successful. The primary endpoint is not statistically powered. The six eligible implanted cases will be evaluated as a proportion of success accompanied by a 95% exact confidence interval and presented alongside the ADVANCE results for visual comparison.

Inclusion Criteria:

1. Patients with irreversible end-stage heart failure of New York Heart Association (NYHA) class III or IV and a history of class IV who are eligible for heart transplantation.
2. Patients who are dependent on medication of inotropes or intra-aortic balloon pump (IABP).
3. Body Surface Area (BSA) ≥1.2 m2. In addition other factors may be taken into consideration, including chest size, abdominal fat (lack of abdominal fat may preclude a pump pocket) and any other physical characteristics that might be benefited by an intra-pericardial pump in a small person.
4. Patients who are aged less than 65 years of age.
5. Patients must be able to understand the limits and complications associated with the HW005 Ventricular Assist System.
6. Female patients of childbearing potential must agree on contraception for the duration of the study.
7. The patient or the legal representative has signed the informed consent form.

Exclusion Criteria:

1. Severe illness other than heart disease which would exclude cardiac transplantation.

2. Inadequate family/social support.

3. Active, uncontrolled infection despite appropriate antibiotic, antiviral or antifungal treatment.

4. Existence of any ongoing mechanical circulatory support (MCS) other than an IABP.

5. Prior cardiac transplant or cardiomyoplasty.

6. Acute myocardial infarction within 14 days of implant.

7. Uncorrected thrombocytopenia or generalized coagulopathy.

8. Intolerance to anticoagulant or antiplatelet therapies or any other peri- or postoperative therapy that the investigator may administer based upon the patient's health status.

9. Patients for whom the use of a left ventricular assist device (LVAD) is contraindicated due to an ongoing aortic/cardiac aneurysm, intraventricular septum rupture and/or use of a mechanical heart valve.

10. Etiology of heart failure is due to, or associated with, uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, active myocarditis or restrictive cardiomyopathy.

11. Patients with irreversible hepatic dysfunction.

12. Patients with irreversible renal dysfunction.

13. Pregnancy.

14. Patients with serious chronic obstructive pulmonary disease (COPD) (Forced Expiratory Volume in the first second (FEV1) < 50%).

15. Pulmonary vascular resistance is unresponsive (fixed) to pharmacologic manipulation as demonstrated by a pulmonary artery systolic pressure exceeding 60mmHg in conjunction with any one of the two following variables:

    • Pulmonary vascular resistance is greater than 6 Woods Units or
    • Transpulmonary gradient exceeds 15 mmHg

16. Cardiothoracic surgery within 14 days of implantation.

17. Peripheral vascular disease with rest pain or ischemic ulcers of the extremities.

18. Pulmonary embolus within three weeks of enrollment as documented by computed tomography (CT) scan or nuclear scan.

19. Patients have moderate to severe aortic insufficiency without plans for correction during pump implantation surgery. Correction may include aortic valve repair at the time of implant.

20. The patient who has advanced calcification in the ascending aorta and/or the descending aorta.

21. Serious right heart failure as defined by the anticipated need for right ventricular assist device (RVAD) support or extracorporeal membrane oxygenation (ECMO) at the time of screening.

22. Patients with severe central nervous system disorder or severe cerebral vascular disorder.

23. Patients with a history of drug intoxication, alcohol dependence.

24. Patients unwilling or unable to comply with study requirements.

25. Patients who refuse transfusion.

26. Patients who in the investigator judgement are deemed to be unsuitable as a subject.

27. Patients who are participating in another clinical trial involving investigational drugs or devices.