Trial Outcomes & Findings for Clinical Evaluation of HW005 Ventricular Assist System for the Treatment of Advanced Heart Failure in Japan (NCT NCT02091440)
NCT ID: NCT02091440
Last Updated: 2019-09-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
6 participants
Primary outcome timeframe
180 days
Results posted on
2019-09-09
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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6
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Overall Study
Primary Endpoint (Success at 180 Days)
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6
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Overall Study
Overall Survival at 180 Days
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6
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Overall Study
COMPLETED
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4
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Overall Study
NOT COMPLETED
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2
|
Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
Death
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2
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Baseline Characteristics
Clinical Evaluation of HW005 Ventricular Assist System for the Treatment of Advanced Heart Failure in Japan
Baseline characteristics by cohort
| Measure |
HW005 Ventricular Assist System
n=6 Participants
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.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=99 Participants
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Age, Categorical
Between 18 and 65 years
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6 Participants
n=99 Participants
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Age, Categorical
>=65 years
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0 Participants
n=99 Participants
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Sex: Female, Male
Female
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3 Participants
n=99 Participants
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Sex: Female, Male
Male
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3 Participants
n=99 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Asian
|
6 Participants
n=99 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=99 Participants
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Race (NIH/OMB)
White
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0 Participants
n=99 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=99 Participants
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Region of Enrollment
Japan
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6 participants
n=99 Participants
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New York Heart Association (NYHA) Classification
Class I
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0 Participants
n=99 Participants
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New York Heart Association (NYHA) Classification
Class II
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0 Participants
n=99 Participants
|
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New York Heart Association (NYHA) Classification
Class III
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3 Participants
n=99 Participants
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New York Heart Association (NYHA) Classification
Class IV
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3 Participants
n=99 Participants
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Six-Minute Walk Test
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135.8 meters
STANDARD_DEVIATION 160.12 • n=99 Participants
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Kansas City Cardiomyopathy Questionnaire (KCCQ) scores
KCCQ Physical Limitation
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45.0 units on a scale
STANDARD_DEVIATION 31.69 • n=99 Participants
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Kansas City Cardiomyopathy Questionnaire (KCCQ) scores
KCCQ Symptom Stability
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37.5 units on a scale
STANDARD_DEVIATION 26.22 • n=99 Participants
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Kansas City Cardiomyopathy Questionnaire (KCCQ) scores
KCCQ Self-Efficacy
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75.0 units on a scale
STANDARD_DEVIATION 22.36 • n=99 Participants
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Kansas City Cardiomyopathy Questionnaire (KCCQ) scores
KCCQ Quality of Life
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31.9 units on a scale
STANDARD_DEVIATION 27.09 • n=99 Participants
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Kansas City Cardiomyopathy Questionnaire (KCCQ) scores
KCCQ Social Limitation
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9.4 units on a scale
STANDARD_DEVIATION 13.26 • n=99 Participants
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Kansas City Cardiomyopathy Questionnaire (KCCQ) scores
KCCQ Overall Summary Score
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45.5 units on a scale
STANDARD_DEVIATION 28.44 • n=99 Participants
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Kansas City Cardiomyopathy Questionnaire (KCCQ) scores
KCCQ Clinical Summary Score
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56.4 units on a scale
STANDARD_DEVIATION 33.89 • n=99 Participants
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Kansas City Cardiomyopathy Questionnaire (KCCQ) scores
KCCQ Symptom Frequency
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66.0 units on a scale
STANDARD_DEVIATION 39.91 • n=99 Participants
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Kansas City Cardiomyopathy Questionnaire (KCCQ) scores
KCCQ Symptom Burden
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69.4 units on a scale
STANDARD_DEVIATION 38.97 • n=99 Participants
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Kansas City Cardiomyopathy Questionnaire (KCCQ) scores
KCCQ Total Symptom Score
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67.7 units on a scale
STANDARD_DEVIATION 39.32 • n=99 Participants
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PRIMARY outcome
Timeframe: 180 daysThe 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.
Outcome measures
| Measure |
HW005 Ventricular Assist System
n=6 Participants
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.
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|---|---|
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Number of Participants Alive on the Implanted HW005 Ventricular Assist System or Transplanted or Explanted for Recovery at 180 Days
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6 Participants
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SECONDARY outcome
Timeframe: 180 daysOutcome measures
| Measure |
HW005 Ventricular Assist System
n=6 Participants
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.
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|---|---|
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Number of Participants Alive on the Implanted HW005 Ventricular Assist System at 180 Days
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6 Participants
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SECONDARY outcome
Timeframe: Through study completion, an average of 44.5 monthsSAEs 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.
Outcome measures
| Measure |
HW005 Ventricular Assist System
n=6 Participants
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.
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|---|---|
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Incidence of All Serious Adverse Events (SAEs) and Unanticipated Adverse Device Effects (UADEs)
J-MACS SAEs
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1.24 event rate per patient year
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Incidence of All Serious Adverse Events (SAEs) and Unanticipated Adverse Device Effects (UADEs)
UADEs
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0 event rate per patient year
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SECONDARY outcome
Timeframe: Through study completion, an average of 44.5 monthsThe 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.
Outcome measures
| Measure |
HW005 Ventricular Assist System
n=6 Participants
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.
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|---|---|
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Incidence of All Device Failures and Device Malfunctions.
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1.66 event rate per patient year
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SECONDARY outcome
Timeframe: Screening, Month 6 (180 days) and Month 24 (after follow-up (FU) completion)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.
Outcome measures
| Measure |
HW005 Ventricular Assist System
n=6 Participants
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.
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|---|---|
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Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life Score at 6 and 24 Months
Month 6
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22.2 score on a scale
Standard Deviation 12.55
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Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life Score at 6 and 24 Months
Month 24
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19.4 score on a scale
Standard Deviation 11.39
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SECONDARY outcome
Timeframe: Screening, Month 6 (180 days) and Month 24 (after FU completion)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.
Outcome measures
| Measure |
HW005 Ventricular Assist System
n=6 Participants
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.
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|---|---|
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Change in NYHA Patient Classification (Patient Functional Status) at 6 and 24 Months
Screening · Class I
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0 Participants
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Change in NYHA Patient Classification (Patient Functional Status) at 6 and 24 Months
Screening · Class II
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0 Participants
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Change in NYHA Patient Classification (Patient Functional Status) at 6 and 24 Months
Screening · Class III
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3 Participants
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Change in NYHA Patient Classification (Patient Functional Status) at 6 and 24 Months
Screening · Class IV
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3 Participants
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Change in NYHA Patient Classification (Patient Functional Status) at 6 and 24 Months
Month 6 · Class I
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1 Participants
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Change in NYHA Patient Classification (Patient Functional Status) at 6 and 24 Months
Month 6 · Class II
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5 Participants
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Change in NYHA Patient Classification (Patient Functional Status) at 6 and 24 Months
Month 6 · Class III
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0 Participants
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Change in NYHA Patient Classification (Patient Functional Status) at 6 and 24 Months
Month 6 · Class IV
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0 Participants
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Change in NYHA Patient Classification (Patient Functional Status) at 6 and 24 Months
Month 24 · Class I
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2 Participants
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Change in NYHA Patient Classification (Patient Functional Status) at 6 and 24 Months
Month 24 · Class II
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3 Participants
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Change in NYHA Patient Classification (Patient Functional Status) at 6 and 24 Months
Month 24 · Class III
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1 Participants
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Change in NYHA Patient Classification (Patient Functional Status) at 6 and 24 Months
Month 24 · Class IV
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0 Participants
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SECONDARY outcome
Timeframe: Screening, Month 6 (180 days) and Month 24 (after FU completion)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.
Outcome measures
| Measure |
HW005 Ventricular Assist System
n=6 Participants
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.
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|---|---|
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Change in Patient 6-minute Walk Distance (Patient Functional Status) at 6 and 24 Months
Month 6
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198.2 Meters
Standard Deviation 217.01
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Change in Patient 6-minute Walk Distance (Patient Functional Status) at 6 and 24 Months
Month 24
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130.0 Meters
Standard Deviation 275.32
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Adverse Events
HW005 Ventricular Assist System
Serious events: 5 serious events
Other events: 6 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
HW005 Ventricular Assist System
n=6 participants at risk
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.
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|---|---|
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Injury, poisoning and procedural complications
Bleeding requiring re-hospitalization
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33.3%
2/6 • Number of events 2 • Through study completion, an average of 44.5 months
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Injury, poisoning and procedural complications
Bleeding requiring re-operation
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33.3%
2/6 • Number of events 2 • Through study completion, an average of 44.5 months
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Cardiac disorders
Ventricular Cardiac Arrhythmia
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33.3%
2/6 • Number of events 2 • Through study completion, an average of 44.5 months
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Cardiac disorders
Supraventricular Cardiac Arrhythmia
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33.3%
2/6 • Number of events 3 • Through study completion, an average of 44.5 months
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Infections and infestations
Sepsis
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16.7%
1/6 • Number of events 2 • Through study completion, an average of 44.5 months
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Infections and infestations
Driveline Exit Site Infection
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16.7%
1/6 • Number of events 1 • Through study completion, an average of 44.5 months
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Vascular disorders
Hemorrhagic Cerebrovascular Accident
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16.7%
1/6 • Number of events 3 • Through study completion, an average of 44.5 months
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Cardiac disorders
Pericardial Fluid Collection
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33.3%
2/6 • Number of events 2 • Through study completion, an average of 44.5 months
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Renal and urinary disorders
Chronic Renal Dysfunction
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16.7%
1/6 • Number of events 1 • Through study completion, an average of 44.5 months
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Respiratory, thoracic and mediastinal disorders
Respiratory Dysfunction
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16.7%
1/6 • Number of events 1 • Through study completion, an average of 44.5 months
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Cardiac disorders
Right Heart Failure requiring inotropic therapy
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16.7%
1/6 • Number of events 2 • Through study completion, an average of 44.5 months
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General disorders
Other
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50.0%
3/6 • Number of events 5 • Through study completion, an average of 44.5 months
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Other adverse events
| Measure |
HW005 Ventricular Assist System
n=6 participants at risk
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.
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|---|---|
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Injury, poisoning and procedural complications
Bleeding requiring re-hospitalization
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33.3%
2/6 • Number of events 2 • Through study completion, an average of 44.5 months
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Injury, poisoning and procedural complications
Bleeding requiring re-operation
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33.3%
2/6 • Number of events 2 • Through study completion, an average of 44.5 months
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Cardiac disorders
Ventricular Cardiac Arrhythmia
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50.0%
3/6 • Number of events 3 • Through study completion, an average of 44.5 months
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Cardiac disorders
Supraventricular Cardiac Arrhythmia
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50.0%
3/6 • Number of events 4 • Through study completion, an average of 44.5 months
|
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Product Issues
Device Malfunction/Failure
|
33.3%
2/6 • Number of events 5 • Through study completion, an average of 44.5 months
|
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Infections and infestations
Sepsis
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16.7%
1/6 • Number of events 2 • Through study completion, an average of 44.5 months
|
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Infections and infestations
Driveline Exit Site Infection
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33.3%
2/6 • Number of events 2 • Through study completion, an average of 44.5 months
|
|
Vascular disorders
Hemorrhagic Cerebrovascular Accident
|
16.7%
1/6 • Number of events 3 • Through study completion, an average of 44.5 months
|
|
Cardiac disorders
Pericardial Fluid Collection
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33.3%
2/6 • Number of events 2 • Through study completion, an average of 44.5 months
|
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Renal and urinary disorders
Acute Renal Dysfunction
|
16.7%
1/6 • Number of events 1 • Through study completion, an average of 44.5 months
|
|
Renal and urinary disorders
Chronic Renal Dysfunction
|
16.7%
1/6 • Number of events 1 • Through study completion, an average of 44.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Dysfunction
|
16.7%
1/6 • Number of events 1 • Through study completion, an average of 44.5 months
|
|
Cardiac disorders
Right Heart Failure requiring inotropic therapy
|
16.7%
1/6 • Number of events 2 • Through study completion, an average of 44.5 months
|
|
General disorders
Other
|
100.0%
6/6 • Number of events 86 • Through study completion, an average of 44.5 months
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI cannot disclose the trial results without the sponsor's permission. The disclosure restriction is not limited by a set period.
- Publication restrictions are in place
Restriction type: OTHER