Human/Machine Interface: What the HeartMate 3 ® Device Tells Us About the Future

Summary

Durable left ventricular assist devices (dLVAD) have been increasingly utilized since the mid to late 1990s, with an uptick of utility starting in 2010 following expanded indications for therapy to not only include a bridge to transplantation strategy, but also for those individuals who suffer from advanced heart failure (HF) and do not qualify for cardiac transplantation. Despite the decreasing size of the newest generation devices leading to a lessened occurrence of adverse events, bleeding and infection still remain a concern for clinicians, as well as a general lack of predictability towards adverse events in individuals with a dLVAD in place. There is a lack of description in the literature currently, regarding the interface between what the pump data provides and what is seen in clinical practice. There also is little known about the effects of what is provided in the pump data, in correlation to quality-of-life following dLVAD implantation.

Therefore, the purpose of this study is to prospectively analyze normal and abnormal pump data through pump operations such as suction events, low flow alarms as well as other adventitious alarms, PI events and power cable disconnects greater than 20 seconds, from the HeartMate 3 ® dLVAD in order to clinically correlate this data to quality of life, frailty and other various medical conditions and adverse events as defined by the Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs). This will be achieved through two aims: 1) Evaluate the effectiveness of dLVAD pump operations data on clinical practice application (quality of life, frailty and various medical conditions, and adverse events such as GIB, RHF, infection, hypertension, arrhythmias and stroke); and 2) Evaluate correlations and relationships of longitudinal normal and abnormal dLVAD pump operations data, to demographic and clinical variables. This study is the first study to evaluate HeartMate 3 ® dLVAD pump operations data over time for effectiveness in the clinical practice.

Conditions

• LVAD
• Frailty
• GI Bleed
• Right Heart Failure
• Infections
• Hypertension
• Arrhythmias
• Stroke

Interventions

DEVICE

HeartMate 3 (R) left ventricular assist device

No direct intervention; this is prospective study analysis of pump data from the HeartMate 3 (R) left ventricular assist device with clinical correlation to a multitude of variables and conditions we see clinically

Sponsors & Collaborators

• Abbott

  collaborator INDUSTRY

• Medical University of Vienna

  collaborator OTHER

• Mayo Clinic

  collaborator OTHER

• University of Florida

  collaborator OTHER

• University of Utah

  collaborator OTHER

• University of Kansas Medical Center

  collaborator OTHER

• Medical University of South Carolina

  collaborator OTHER

• University of Chicago

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• International Consortium of Circulatory Assist Clinicians

  lead OTHER

Principal Investigators

• Sarah E Schroeder, PhD MSN RN · International Consortium of Circulatory Assist Clinicians

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-10-27

Primary Completion

2026-12-30

Completion

2026-12-30

FDA Device

Yes

Countries

• United States

Study Locations