Studies how HeartMate 3 pump data relates to patient health and quality of life
Observes heart pump data and health in adults with advanced heart failure.
Plain-language title generated from the registry record
Registry title: Human/Machine Interface: What the HeartMate 3 ® Device Tells Us About the Future
Key facts
- Where
- Charleston, Chicago, Gainesville, Kansas City, Rochester, Salt Lake City, and San Francisco, United StatesSee the 7 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 100 years old?
Source: NCT06039176, who can take part
Where in United States
- MUSCCharleston, United StatesNo longer taking part
- University of ChicagoChicago, United StatesTaking people
- University of FloridaGainesville, United StatesTaking people
- University of Kansas Medical CenterKansas City, United StatesNo longer taking part
- Mayo Clinic - RochesterRochester, United StatesTaking people
- University of UtahSalt Lake City, United StatesNo longer taking part
- UCSFSan Francisco, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- International Consortium of Circulatory Assist Clinicians
- Trial code
- NCT06039176
- Record updated
- 16 December 2025
- Original description
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.Read full original descriptionShow less
Human/Machine Interface: What the HeartMate 3 ® Device Tells Us About the Future
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.
Inclusion: 18 years of age or older; Scheduled Heartmate 3 ® dLVAD implantation.
Exclusion: <18 years of age; Scheduled for dLVAD that is NOT a Heartmate 3 (R) device.