Back to resultsClinical Evaluation of HW005 Ventricular Assist System for the Treatment of Advanced Heart Failure in Japan (HW005)
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Implant of the HW005 Ventricular Assist System.
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Medical Device, Thoracic Surgical Procedure, Pumps Heart Assist, Ventricular Assist Device
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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:
- Pulmonary vascular resistance is greater than 6 Woods Units or
- Transpulmonary gradient exceeds 15 mmHg
- Cardiothoracic surgery within 14 days of implantation.
- Peripheral vascular disease with rest pain or ischemic ulcers of the extremities.
- Pulmonary embolus within three weeks of enrollment as documented by computed tomography (CT) scan or nuclear scan.
- 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.
- The patient who has advanced calcification in the ascending aorta and/or the descending aorta.
- 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.
- Patients with severe central nervous system disorder or severe cerebral vascular disorder.
- Patients with a history of drug intoxication, alcohol dependence.
- Patients unwilling or unable to comply with study requirements.
- Patients who refuse transfusion.
- Patients who in the investigator judgement are deemed to be unsuitable as a subject.
- Patients who are participating in another clinical trial involving investigational drugs or devices.
Sites / Locations
- Kyushu University Hospital
- Tohoku University Hospital
- Osaka University Hospital
- National Cerebral and Cardiovascular Center Hospital
- The University of Tokyo Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
HW005 Ventricular Assist System
Arm Description
Implant of the HW005 Ventricular Assist System.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of Participants Alive on the Implanted HW005 Ventricular Assist System at 180 Days
Incidence of All Serious Adverse Events (SAEs) and Unanticipated Adverse Device Effects (UADEs)
SAEs are defined as events that result in death, are life-threatening, result in permanent disability, require medical treatment to prevent permanent disability or require surgical intervention or hospitalization.
UADEs are defined as any serious adverse device effect which by its nature, incidence, severity or outcome has not been identified in the current version of the risk analysis report.
Events were categorized using the Japanese registry for Mechanically Assisted Circulatory Support (J-MACS) definitions.
Incidence of All Device Failures and Device Malfunctions.
The device failures and malfunctions are the failures on pumping function due to thrombosis inside/outside of the implanted pump, the mechanical failures of the implanted components, the mechanical failures of the external components and the failures due to the user.
Events were categorized using the J-MACS definitions.
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life Score at 6 and 24 Months
The KCCQ is a self-evaluation questionnaire for patients with heart failure to assess the severity of their symptoms how it may affect their lives. Scores range between 0 (worst) - 100 (best).
Values in the table were calculated as the value at Month 6 (180 days) minus Screening and at Month 24 (after FU completion) minus Screening.
The positive change in KCCQ score indicates an improvement in patient Quality of Life.
Change in NYHA Patient Classification (Patient Functional Status) at 6 and 24 Months
The New York Heart Association (NYHA) Functional Classification places patients with heart failure in one of four categories based on how much they are limited during physical activity.
Class I (best): No limitation of physical activity.
Class II: Slight limitation of physical activity. Comfortable at rest.
Class III: Marked limitation of physical activity. Comfortable at rest.
Class IV (worst): Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest.
A shift from a higher class (e.g. Class IV) to a lower class (e.g. Class II) indicates an improvement in patient health and functional status.
Change in Patient 6-minute Walk Distance (Patient Functional Status) at 6 and 24 Months
For the 6-minute walk test, the patient is asked to walk for 6 minutes. The total distance walked is measured.
Values in the table were calculated as the value at Month 6 (180 days) minus Screening and at Month 24 (after FU completion) minus Screening.
A positive change in 6-minute walk distance indicates an improvement in health and functional status.
Full Information
NCT ID
NCT02091440
First Posted
March 17, 2014
Last Updated
July 26, 2019
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
1. Study Identification
Unique Protocol Identification Number
NCT02091440
Brief Title
Clinical Evaluation of HW005 Ventricular Assist System for the Treatment of Advanced Heart Failure in Japan
Acronym
HW005
Official Title
Clinical Evaluation of the HW005 Ventricular Assist System for the Treatment of Advanced Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
December 6, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Medical Device, Thoracic Surgical Procedure, Pumps Heart Assist, Ventricular Assist Device
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HW005 Ventricular Assist System
Arm Type
Other
Arm Description
Implant of the HW005 Ventricular Assist System.
Intervention Type
Device
Intervention Name(s)
Implant of the HW005 Ventricular Assist System.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants Alive on the Implanted HW005 Ventricular Assist System or Transplanted or Explanted for Recovery at 180 Days
Description
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.
Time Frame
180 days
Secondary Outcome Measure Information:
Title
Number of Participants Alive on the Implanted HW005 Ventricular Assist System at 180 Days
Time Frame
180 days
Title
Incidence of All Serious Adverse Events (SAEs) and Unanticipated Adverse Device Effects (UADEs)
Description
SAEs are defined as events that result in death, are life-threatening, result in permanent disability, require medical treatment to prevent permanent disability or require surgical intervention or hospitalization.
UADEs are defined as any serious adverse device effect which by its nature, incidence, severity or outcome has not been identified in the current version of the risk analysis report.
Events were categorized using the Japanese registry for Mechanically Assisted Circulatory Support (J-MACS) definitions.
Time Frame
Through study completion, an average of 44.5 months
Title
Incidence of All Device Failures and Device Malfunctions.
Description
The device failures and malfunctions are the failures on pumping function due to thrombosis inside/outside of the implanted pump, the mechanical failures of the implanted components, the mechanical failures of the external components and the failures due to the user.
Events were categorized using the J-MACS definitions.
Time Frame
Through study completion, an average of 44.5 months
Title
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life Score at 6 and 24 Months
Description
The KCCQ is a self-evaluation questionnaire for patients with heart failure to assess the severity of their symptoms how it may affect their lives. Scores range between 0 (worst) - 100 (best).
Values in the table were calculated as the value at Month 6 (180 days) minus Screening and at Month 24 (after FU completion) minus Screening.
The positive change in KCCQ score indicates an improvement in patient Quality of Life.
Time Frame
Screening, Month 6 (180 days) and Month 24 (after follow-up (FU) completion)
Title
Change in NYHA Patient Classification (Patient Functional Status) at 6 and 24 Months
Description
The New York Heart Association (NYHA) Functional Classification places patients with heart failure in one of four categories based on how much they are limited during physical activity.
Class I (best): No limitation of physical activity.
Class II: Slight limitation of physical activity. Comfortable at rest.
Class III: Marked limitation of physical activity. Comfortable at rest.
Class IV (worst): Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest.
A shift from a higher class (e.g. Class IV) to a lower class (e.g. Class II) indicates an improvement in patient health and functional status.
Time Frame
Screening, Month 6 (180 days) and Month 24 (after FU completion)
Title
Change in Patient 6-minute Walk Distance (Patient Functional Status) at 6 and 24 Months
Description
For the 6-minute walk test, the patient is asked to walk for 6 minutes. The total distance walked is measured.
Values in the table were calculated as the value at Month 6 (180 days) minus Screening and at Month 24 (after FU completion) minus Screening.
A positive change in 6-minute walk distance indicates an improvement in health and functional status.
Time Frame
Screening, Month 6 (180 days) and Month 24 (after FU completion)
10. Eligibility
Sex
All
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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:
Pulmonary vascular resistance is greater than 6 Woods Units or
Transpulmonary gradient exceeds 15 mmHg
Cardiothoracic surgery within 14 days of implantation.
Peripheral vascular disease with rest pain or ischemic ulcers of the extremities.
Pulmonary embolus within three weeks of enrollment as documented by computed tomography (CT) scan or nuclear scan.
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.
The patient who has advanced calcification in the ascending aorta and/or the descending aorta.
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.
Patients with severe central nervous system disorder or severe cerebral vascular disorder.
Patients with a history of drug intoxication, alcohol dependence.
Patients unwilling or unable to comply with study requirements.
Patients who refuse transfusion.
Patients who in the investigator judgement are deemed to be unsuitable as a subject.
Patients who are participating in another clinical trial involving investigational drugs or devices.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoshiki Sawa, MD
Organizational Affiliation
Osaka University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyushu University Hospital
City
Fukuoka
State/Province
Kyushu
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai
State/Province
Tohoku
ZIP/Postal Code
980-8547
Country
Japan
Facility Name
Osaka University Hospital
City
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
National Cerebral and Cardiovascular Center Hospital
City
Osaka
ZIP/Postal Code
565-8565
Country
Japan
Facility Name
The University of Tokyo Hospital
City
Tokyo
ZIP/Postal Code
113-8655
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation of HW005 Ventricular Assist System for the Treatment of Advanced Heart Failure in Japan
We'll reach out to this number within 24 hrs