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

NCT02091440 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2019-09-09

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • Yoshiki Sawa, MD · Osaka University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-03-31
Completion
2018-12-06

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02091440 on ClinicalTrials.gov