Human/Machine Interface: What the HeartMate 3 ® Device Tells Us About the Future
Recruiting · NCT06039176 · Observational (researchers observe without assigning treatment) · Lead sponsor: International Consortium of Circulatory Assist Clinicians
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
14 locations listed across 7 US states.
- UCSF - San Francisco, California, United States
- UCSF - San Francisco, California, United States
- University of Florida - Gainesville, Florida, United States
- University of Florida - Gainesville, Florida, United States
- University of Chicago - Chicago, Illinois, United States
- University of Chicago - Chicago, Illinois, United States
- University of Kansas Medical Center - Kansas City, Kansas, United States
- University of Kansas Medical Center - Kansas City, Kansas, United States
- Mayo Clinic-Rochester - Rochester, Minnesota, United States
- Mayo Clinic-Rochester - Rochester, Minnesota, United States
- MUSC - Charleston, South Carolina, United States
- MUSC - Charleston, South Carolina, United States
- University of Utah - Salt Lake City, Utah, United States
- University of Utah - Salt Lake City, Utah, United States