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

NCT02091440 | Completed Results

• 1 other identifier: HW005/ Japan
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Heart Failure

Keywords

Medical Device; Thoracic Surgical Procedure; Pumps Heart Assist; Ventricular Assist Device

Outcome Measures

Primary Outcomes (1)

• Number of Participants Alive on the Implanted HW005 Ventricular Assist System or Transplanted or Explanted for Recovery at 180 Days

  The primary endpoint is success at 180 days which is defined as alive on the originally implanted HW005 Ventricular Assist System or transplanted or explanted for recovery. Patients must survive 60 days post-explant for recovery to be considered successful.

  180 days

Secondary Outcomes (6)

• Number of Participants Alive on the Implanted HW005 Ventricular Assist System at 180 Days

  180 days

• Incidence of All Serious Adverse Events (SAEs) and Unanticipated Adverse Device Effects (UADEs)

  Through study completion, an average of 44.5 months

• Incidence of All Device Failures and Device Malfunctions.

  Through study completion, an average of 44.5 months

• Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life Score at 6 and 24 Months

  Screening, Month 6 (180 days) and Month 24 (after follow-up (FU) completion)

• Change in NYHA Patient Classification (Patient Functional Status) at 6 and 24 Months

  Screening, Month 6 (180 days) and Month 24 (after FU completion)

Study Arms (1)

HW005 Ventricular Assist System

OTHER

Implant of the HW005 Ventricular Assist System.

Device: Implant of the HW005 Ventricular Assist System.

Interventions

Implant of the HW005 Ventricular Assist System. DEVICE

The HW005 Pump is in implantable centrifugal pump that was designed to provide flows up to 10 L/min. It is a small device which is both lightweight and simple to use.

HW005 Ventricular Assist System

Eligibility Criteria

• Age: Up to 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients who are dependent on medication of inotropes or intra-aortic balloon pump (IABP).
• 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.
• Patients who are aged less than 65 years of age.
• Patients must be able to understand the limits and complications associated with the HW005 Ventricular Assist System.
• Female patients of childbearing potential must agree on contraception for the duration of the study.
• The patient or the legal representative has signed the informed consent form.

You may not qualify if:

• Severe illness other than heart disease which would exclude cardiac transplantation.
• Inadequate family/social support.
• Active, uncontrolled infection despite appropriate antibiotic, antiviral or antifungal treatment.
• Existence of any ongoing mechanical circulatory support (MCS) other than an IABP.
• Prior cardiac transplant or cardiomyoplasty.
• Acute myocardial infarction within 14 days of implant.
• Uncorrected thrombocytopenia or generalized coagulopathy.
• 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.
• 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.
• Etiology of heart failure is due to, or associated with, uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, active myocarditis or restrictive cardiomyopathy.
• Patients with irreversible hepatic dysfunction.
• Patients with irreversible renal dysfunction.
• Pregnancy.
• Patients with serious chronic obstructive pulmonary disease (COPD) (Forced Expiratory Volume in the first second (FEV1) \< 50%).
• 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:

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (5)

Kyushu University Hospital

Fukuoka, Kyushu, 812-8582, Japan

Location

Tohoku University Hospital

Sendai, Tohoku, 980-8547, Japan

Location

Osaka University Hospital

Osaka, 565-0871, Japan

Location

National Cerebral and Cardiovascular Center Hospital

Osaka, 565-8565, Japan

Location

The University of Tokyo Hospital

Tokyo, 113-8655, Japan

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Prof. Yoshiki Sawa
• Organization: Osaka University Hospital

sawa@surg1.med.osaka-u.ac.jp

+81 668793160

Study Officials

• Yoshiki Sawa, MD

  Osaka University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2014
• First Posted: March 19, 2014
• Study Start: March 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: December 6, 2018
• Last Updated: September 9, 2019
• Results First Posted: September 9, 2019

Record last verified: 2019-07

Locations

JP (5)