Human/Machine Interface: What the HeartMate 3 ® Device Tells Us About the Future
Who can join
Ages 18 to 100 · All sexes
Full eligibility criteria
Inclusion Criteria: * 18 years of age or older * Scheduled Heartmate 3 ® dLVAD implantation Exclusion Criteria: * \<18 years of age * Scheduled for dLVAD that is NOT a Heartmate 3 (R) device
About the study
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.
What is being tested
- HeartMate 3 (R) left ventricular assist device (device)
Sponsor: International Consortium of Circulatory Assist Clinicians · Participants: 150 · Started: Oct 27, 2023
Contact the study team
- Sarah E Schroeder, PhD MSN RN · Phone: 402-937-3595
- Thomas Schloglhofer, MSc · Phone: +43 650 7119129
Official record on ClinicalTrials.gov — NCT06039176
Locations in the U.S.
| California | UCSF, San Francisco |
| Florida | University of Florida, Gainesville |
| Illinois | University of Chicago, Chicago |
| Minnesota | Mayo Clinic-Rochester, Rochester |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.