Trials / Completed
CompletedNCT02091440
Clinical Evaluation of HW005 Ventricular Assist System for the Treatment of Advanced Heart Failure in Japan
Clinical Evaluation of the HW005 Ventricular Assist System for the Treatment of Advanced Heart Failure
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure · Industry
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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. |
Timeline
- Start date
- 2014-03-01
- Primary completion
- 2015-03-01
- Completion
- 2018-12-06
- First posted
- 2014-03-19
- Last updated
- 2019-09-09
- Results posted
- 2019-09-09
Locations
5 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT02091440. Inclusion in this directory is not an endorsement.