Heart FailureHW005NCT02091440
Clinical Evaluation of HW005 Ventricular Assist System for the Treatment of Advanced Heart Failure in Japan
A study testing Implant of the HW005 Ventricular Assist System. in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 5 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Implant of the HW005 Ventricular Assist System.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 5 sitesJapan
- Study dates
- Mar 2014to 6 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Japan5 sites
Kyushu University Hospital
Fukuoka, Kyushu, 812-8582
Osaka University Hospital
Osaka, 565-0871
National Cerebral and Cardiovascular Center Hospital
Osaka, 565-8565
Tohoku University Hospital
Sendai, Tohoku, 980-8547
The University of Tokyo Hospital
Tokyo, 113-8655
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Implant of the HW005 Ventricular Assist System.
- Keywords
- Medical Device, Thoracic Surgical Procedure, Pumps Heart Assist, Ventricular Assist Device
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| HW005 Ventricular Assist System | Other | Implant of the HW005 Ventricular Assist System. Receives: Device: Implant of the HW005 Ventricular Assist System. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 180 days
Secondary outcomes (6)
Number of Participants Alive on the Implanted HW005 Ventricular Assist System at 180 Days
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Screening, Month 6 (180 days) and Month 24 (after FU completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2015
- Study completion6 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yoshiki Sawa, MD, Principal investigator, Osaka University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02091440
- Sponsor's protocol ID
- HW005/ Japan
- Acronym
- HW005
- Status last verified
- Jul 2019
- First submitted
- 17 Mar 2014
- Last updated
- 9 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the HW005 Ventricular Assist System for the Treatment of Advanced Heart Failure
- ClinicalTrials.gov ID
- NCT02091440
- Acronym / sponsor ID
- HW005 / HW005/ Japan
- Conditions
- Heart Failure
- Keywords
- Medical Device, Thoracic Surgical Procedure, Pumps Heart Assist, Ventricular Assist Device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- 6 Dec 2018 (actual)
- First posted
- 19 Mar 2014 (estimated)
- Results
- Posted 9 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HW005 Ventricular Assist System | Other | Device: Implant of the HW005 Ventricular Assist System.Implant of the HW005 Ventricular Assist System. |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (29 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implant of the HW005 Ventricular Assist System.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. | Device | HW005 Ventricular Assist System |
Primary outcome
Number of Participants Alive on the Implanted HW005 Ventricular Assist System or Transplanted or Explanted for Recovery at 180 Days
Time frame: 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.
6 secondary outcomes
Number of Participants Alive on the Implanted HW005 Ventricular Assist System at 180 Days
Time frame: 180 days
Incidence of All Serious Adverse Events (SAEs) and Unanticipated Adverse Device Effects (UADEs)
Time frame: Through study completion, an average of 44.5 months
Incidence of All Device Failures and Device Malfunctions.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Screening, Month 6 (180 days) and Month 24 (after FU completion)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoshiki Sawa, MD principal investigator
Osaka University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implant of the HW005 Ventricular Assist System. in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 5 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Alive on the Implanted HW005 Ventricular Assist System or Transplanted or Explanted for Recovery at 180 Days (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2019.