Actively Recruiting

Age: 18Years - 100Years
All Genders
ID06039176

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

Led by International Consortium of Circulatory Assist Clinicians · Updated on 2025-12-16

150

Participants Needed

7

Research Sites

N/A

Total Duration

On this page

Sponsors

I

International Consortium of Circulatory Assist Clinicians

Lead Sponsor

A

Abbott

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying the HeartMate 3 left ventricular assist device (dLVAD) and how its pump data relates to clinical outcomes in people with advanced heart failure. This study aims to understand how normal and abnormal pump events, such as suction events, low flow alarms, and power cable disconnects, connect to quality of life, frailty, medical conditions, and adverse events including gastrointestinal bleeding, right heart failure, infections, hypertension, arrhythmias, and stroke. It is a prospective, multi-center observational study led by the International Consortium of Circulatory Assist Clinicians. Participants will have their HeartMate 3 pump data collected at scheduled times: discharge from the ICU, hospital discharge, 3 months, 6 months, and 12 months after implantation. Data will also be gathered during any unplanned office visits, hospital admissions, or emergency room visits related to the device or adverse events. The study does not involve any additional devices or changes to the pump; it focuses solely on analyzing routine downloadable pump data to evaluate clinical correlations. During the study, researchers will collect clinical and demographic information along with quality of life assessments, frailty measures, and medical condition evaluations. They will analyze how pump data changes over time and relate these findings to patient health outcomes, including survival at 12 months. This comprehensive monitoring aims to improve understanding of how pump data can inform clinical care and predict adverse events in people with a HeartMate 3 dLVAD.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older
  • Scheduled for HeartMate 3 � durable left ventricular assist device implantation
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Scheduled for a durable left ventricular assist device other than HeartMate 3 �

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Up to 12 months post-implant

Participants receive a HeartMate 3® left ventricular assist device implantation as part of their routine medical care. This study analyzes downloadable pump operations data from the device at scheduled intervals.

Visits at discharge from ICU, hospital discharge (±3 days), 3 months, 6 months, 12 months post-implant, and additional visits during any unplanned office visits, hospital admissions, or emergency room visits related to device issues or adverse events

Long-term Monitoring

Duration - Up to 12 months post-implant

Participants are monitored through analysis of longitudinal HeartMate 3® pump operations data and clinical variables to evaluate quality of life, frailty severity, medical conditions, and adverse events such as gastrointestinal bleeding, right heart failure, infection, hypertension, arrhythmias, and stroke.

Ongoing data collection during scheduled and unplanned visits over 12 months

Trial Site Locations

Total: 7 locations

1

UCSF

San Francisco, California, United States, 94143

Actively Recruiting

2

University of Florida

Gainesville, Florida, United States, 32611

Actively Recruiting

3

University of Chicago

Chicago, Illinois, United States, 60637

Actively Recruiting

4

University of Kansas Medical Center

Kansas City, Kansas, United States, 66103

Active, Not Recruiting

5

Mayo Clinic-Rochester

Rochester, Minnesota, United States, 55902

Actively Recruiting

6

MUSC

Charleston, South Carolina, United States, 29425

Active, Not Recruiting

7

University of Utah

Salt Lake City, Utah, United States, 84112

Active, Not Recruiting

Loading map...

Research Team

S

Sarah E Schroeder, PhD MSN RN

T

Thomas Schloglhofer, MSc

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

7

Similar Trials

"Smart Family Doctor" Assisted Comprehensive Management of S...

Post Coronary Artery Bypass Grafting

Actively Recruiting

1 location

The PILI 'Aina Project to Improve Cardiometabolic Health in...

Type 2 Diabetes

Actively Recruiting

2 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Stroke Incidence and Impact of Continuous-Flow Left Ventricular Assist Devices on Cerebrovascular Physiology.

William K Cornwell, Amrut V Ambardekar, Tomio Tran...

https://pubmed.ncbi.nlm.nih.gov/30602359