Clinical research of the left ventricular assist device with post-auricular connector - Clinical research of the left ventricular assist device with post-auricular connector

Sawa Yoshiki0 sites3 target enrollmentNovember 1, 2018

Conditionssevere heart failure

Overview

Phase: N/A
Intervention: Not specified
Conditions: severe heart failure
Sponsor: Sawa Yoshiki
Enrollment: 3
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

Of the three cases in which the study was performed, one died (no causal relationship to the study device), one was discontinued, and one was completed at 6 months. None of the patients had DL infection, which is considered a major complication of implantable ventricular assisted device.

Registry

who.int

Start Date

November 1, 2018

End Date

December 31, 2020

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Sawa Yoshiki

Eligibility Criteria

Inclusion Criteria

•1\) patient who understands the purpose of the study and consents the entry.
•2\) 20 years old or older.
•3\) patient and his family understand and consent end\-of\-life care.
•4\) severe heart failure patient who needs heart transplantation but is ineligible for it.
•5\) New York Heart Association Class IIIb and IV end\-stage left ventricular failure.
•6\) patient who has undergone maximum optimal medical therapy but has been demonstrated to be refractory to it.
•7\) BSA 1\.2\-2\.3m2
•8\)patient who has a care\-giver.

Exclusion Criteria

•1\) J\-macs profile 1
•2\) patients who have uncontrollable severe infections.
•3\) the prognosis of other diseases is less than 3 years.
•4\) patients who underwent open chest surgery less than 2 weeks before.
•5\) patients who has contraindication of LVAD implantation due to aortic or ventricular aneurysm, or VSD etc(exclude the cases who can undergo the surgery at the same time).
•6\) patients who has moderate AR (exclude the cases who can undergo the surgery at the same time).
•7\) patients with severe cerebral or phsychological disease who can't control LVAD.
•8\) patients who has a tendency to bleed.
•9\) pregnant or who wants to became pregnant
•10\)cirrhosis (Child C)