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Clinical Evaluation of HW005 Ventricular Assist System for the Treatment of Advanced Heart Failure in Japan — HW005  

Heart Failure Clinical Trial

Official title:
Clinical Evaluation of the HW005 Ventricular Assist System for the Treatment of Advanced Heart Failure

Clinical 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02091440
Study type Interventional
Source Medtronic Cardiac Rhythm and Heart Failure
Contact
Status Completed
Phase N/A
Start date March 2014
Completion date December 6, 2018
View Details
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