Thoratec Corporation HeartMate 3™ Less Invasive Surgery (LIS) Study

Abbott Medical Devices3 sites in 2 countries13 target enrollmentMay 2015

ConditionsHeart Failure Cardiovascular Disease

Overview

Phase: N/A
Intervention: Not specified
Conditions: Heart Failure
Sponsor: Abbott Medical Devices
Enrollment: 13
Locations: 3
Primary Endpoint: Number of survival participants
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate a less invasive implantation technique of the HeartMate 3 Left Ventricular Assist System (HM 3 LVAS) in 10 patients.

Detailed Description

This study will evaluate the less invasive implantation technique of the HM 3 LVAS.

Registry

clinicaltrials.gov

Start Date

May 2015

End Date

July 2016

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Abbott Medical Devices

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient or legal representative has signed Informed Consent Form (ICF)
•Age ≥ 18 years
•BSA ≥ 1.2 m2
•NYHA IIIB or IV, or ACC/AHA Stage D
•CI ≤ 2.2 L/min/m2, while not on inotropes (if Patient is treated with inotropes at baseline, this does not apply)
•Patients must also meet one of the following:
•On optimal medical management (OMM), based on current heart failure practice guidelines for at least 45 out of the last 60 days and are failing to respond, OR
•In NYHA class IIIB or IV heart failure for at least 14 days AND dependent on intraaortic balloon pump (IABP) for at least 7 days, OR
•Inotrope dependent/unable to wean from inotropes OR
•Listed for transplant

Exclusion Criteria

•Etiology of heart failure (HF) due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis or restrictive cardiomyopathy
•Technical obstacles which pose an inordinately high surgical risk, in the judgment of the Investigator
•Existence of ongoing mechanical circulatory support (MCS) other than IABP
•Positive pregnancy test if of childbearing potential
•Lactating mothers
•Presence of mechanical aortic cardiac valve
•History of any organ transplant
•Platelet count \< 100,000 x 103/L (\< 100,000/ml)
•Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAS management
•History of confirmed, untreated AAA \> 5 cm in diameter