Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HW005 Ventricular Assist System | Other | Implant of the HW005 Ventricular Assist System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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. |
Not provided
Inclusion Criteria:
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yoshiki Sawa, MD | Osaka University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyushu University Hospital | Fukuoka | Kyushu | 812-8582 | Japan | ||
| Tohoku University Hospital |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | HW005 Ventricular Assist System | Implant of the HW005 Ventricular Assist System.: The HW005 Pump is an 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | HW005 Ventricular Assist System | Implant of the HW005 Ventricular Assist System.: The HW005 Pump is an 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 180 days |
|
Through study completion, an average of 44.5 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HW005 Ventricular Assist System | Implant of the HW005 Ventricular Assist System.: The HW005 Pump is an 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding requiring re-hospitalization | Injury, poisoning and procedural complications | J-MACS | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding requiring re-hospitalization | Injury, poisoning and procedural complications | J-MACS | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Yoshiki Sawa | Osaka University Hospital | +81 668793160 | sawa@surg1.med.osaka-u.ac.jp |
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Through study completion, an average of 44.5 months |
| 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. | 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 | 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. | 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 | 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. | Screening, Month 6 (180 days) and Month 24 (after FU completion) |
| 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. | Screening, Month 6 (180 days) and Month 24 (after FU completion) |
| Sendai |
| Tohoku |
| 980-8547 |
| Japan |
| Osaka University Hospital | Osaka | 565-0871 | Japan |
| National Cerebral and Cardiovascular Center Hospital | Osaka | 565-8565 | Japan |
| The University of Tokyo Hospital | Tokyo | 113-8655 | Japan |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| New York Heart Association (NYHA) Classification | 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. | Count of Participants | Participants |
|
| Six-Minute Walk Test | Mean | Standard Deviation | meters |
|
| Kansas City Cardiomyopathy Questionnaire (KCCQ) scores | 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. All scores range between 0 (worst) - 100 (best). For example: Social Limitation score of 100 means no social limitation at all Total Symptom Score: mean of Symptom Frequency and Symptom Burden scores Overall Summary Score: mean of Physical Limitation, Symptom Stability, Total Symptom, Quality of Life and Social Limitation scores Clinical Summary Score: mean of Physical Limitation and Total Symptom scores | Mean | Standard Deviation | units on a scale |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | Number of Participants Alive on the Implanted HW005 Ventricular Assist System at 180 Days | Posted | Count of Participants | Participants | 180 days |
|
|
|
|
| Secondary | 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. | Posted | Number | event rate per patient year | Through study completion, an average of 44.5 months |
|
|
|
|
| Secondary | 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. | Posted | Number | event rate per patient year | Through study completion, an average of 44.5 months |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Screening, Month 6 (180 days) and Month 24 (after follow-up (FU) completion) |
|
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Screening, Month 6 (180 days) and Month 24 (after FU completion) |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Meters | Screening, Month 6 (180 days) and Month 24 (after FU completion) |
|
|
|
|
| 2 |
| 6 |
| 5 |
| 6 |
| 6 |
| 6 |
| Bleeding requiring re-operation | Injury, poisoning and procedural complications | J-MACS | Systematic Assessment |
|
| Ventricular Cardiac Arrhythmia | Cardiac disorders | J-MACS | Systematic Assessment |
|
| Supraventricular Cardiac Arrhythmia | Cardiac disorders | J-MACS | Systematic Assessment |
|
| Sepsis | Infections and infestations | J-MACS | Systematic Assessment |
|
| Driveline Exit Site Infection | Infections and infestations | J-MACS | Systematic Assessment |
|
| Hemorrhagic Cerebrovascular Accident | Vascular disorders | J-MACS | Systematic Assessment |
|
| Pericardial Fluid Collection | Cardiac disorders | J-MACS | Systematic Assessment |
|
| Chronic Renal Dysfunction | Renal and urinary disorders | J-MACS | Systematic Assessment |
|
| Respiratory Dysfunction | Respiratory, thoracic and mediastinal disorders | J-MACS | Systematic Assessment |
|
| Right Heart Failure requiring inotropic therapy | Cardiac disorders | J-MACS | Systematic Assessment |
|
| Other | General disorders | J-MACS | Systematic Assessment |
|
| Bleeding requiring re-operation | Injury, poisoning and procedural complications | J-MACS | Systematic Assessment |
|
| Ventricular Cardiac Arrhythmia | Cardiac disorders | J-MACS | Systematic Assessment |
|
| Supraventricular Cardiac Arrhythmia | Cardiac disorders | J-MACS | Systematic Assessment |
|
| Device Malfunction/Failure | Product Issues | J-MACS | Systematic Assessment |
|
| Sepsis | Infections and infestations | J-MACS | Systematic Assessment |
|
| Driveline Exit Site Infection | Infections and infestations | J-MACS | Systematic Assessment |
|
| Hemorrhagic Cerebrovascular Accident | Vascular disorders | J-MACS | Systematic Assessment |
|
| Pericardial Fluid Collection | Cardiac disorders | J-MACS | Systematic Assessment |
|
| Acute Renal Dysfunction | Renal and urinary disorders | J-MACS | Systematic Assessment |
|
| Chronic Renal Dysfunction | Renal and urinary disorders | J-MACS | Systematic Assessment |
|
| Respiratory Dysfunction | Respiratory, thoracic and mediastinal disorders | J-MACS | Systematic Assessment |
|
| Right Heart Failure requiring inotropic therapy | Cardiac disorders | J-MACS | Systematic Assessment |
|
| Other | General disorders | J-MACS | Systematic Assessment |
|
The PI cannot disclose the trial results without the sponsor's permission. The disclosure restriction is not limited by a set period.
| Class IV |
|
| Month 6 |
|
| Month 24 |
|