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

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 18 years of age or older

• Scheduled Heartmate 3 ® dLVAD implantation

Locations
United States
California
UCSF
RECRUITING
San Francisco
Florida
University of Florida
NOT_YET_RECRUITING
Gainesville
Illinois
University of Chicago
NOT_YET_RECRUITING
Chicago
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Minnesota
Mayo Clinic-Rochester
RECRUITING
Rochester
Ohio
UH Cleveland Medical Center
NOT_YET_RECRUITING
Cleveland
South Carolina
MUSC
RECRUITING
Charleston
Utah
University of Utah
RECRUITING
Salt Lake City
Contact Information
Primary
Sarah E Schroeder, PhD MSN RN
sarah.schroeder@vadcoordinator.org
402-937-3595
Backup
Thomas Schloglhofer, MSc
thomas.schloeglhofer@meduniwien.ac.at
+43 650 7119129
Time Frame
Start Date: 2023-10-27
Estimated Completion Date: 2026-12-25
Participants
Target number of participants: 150
Treatments
Mayo Clinic
Obtain demographic and clinical data prior to and following implantation of a HeartMate 3 ® device. HeartMate 3® downloaded pump operations data will be obtained at the following scheduled intervals: discharge from the ICU, at the time of discharge from the hospital (or ± 3 days from discharge), 3-months post-implant, 6-months post-implant, and lastly at 12-months post-implant. Downloadable pump operations data will include evaluation of suction events, low flow and other adventitious alarms, PI events and incidence of power cable disconnects beyond 20 seconds. The previously mentioned data will also be collected during any unplanned office visits, any admission regardless of the reason, unplanned ER visits related to equipment problems or any serious adverse event-related ER visits.
University of Florida
Obtain demographic and clinical data prior to and following implantation of a HeartMate 3 ® device. HeartMate 3® downloaded pump operations data will be obtained at the following scheduled intervals: discharge from the ICU, at the time of discharge from the hospital (or ± 3 days from discharge), 3-months post-implant, 6-months post-implant, and lastly at 12-months post-implant. Downloadable pump operations data will include evaluation of suction events, low flow and other adventitious alarms, PI events and incidence of power cable disconnects beyond 20 seconds. The previously mentioned data will also be collected during any unplanned office visits, any admission regardless of the reason, unplanned ER visits related to equipment problems or any serious adverse event-related ER visits.
University of Utah
Obtain demographic and clinical data prior to and following implantation of a HeartMate 3 ® device. HeartMate 3® downloaded pump operations data will be obtained at the following scheduled intervals: discharge from the ICU, at the time of discharge from the hospital (or ± 3 days from discharge), 3-months post-implant, 6-months post-implant, and lastly at 12-months post-implant. Downloadable pump operations data will include evaluation of suction events, low flow and other adventitious alarms, PI events and incidence of power cable disconnects beyond 20 seconds. The previously mentioned data will also be collected during any unplanned office visits, any admission regardless of the reason, unplanned ER visits related to equipment problems or any serious adverse event-related ER visits.
University of California, San Francisco
Obtain demographic and clinical data prior to and following implantation of a HeartMate 3 ® device. HeartMate 3® downloaded pump operations data will be obtained at the following scheduled intervals: discharge from the ICU, at the time of discharge from the hospital (or ± 3 days from discharge), 3-months post-implant, 6-months post-implant, and lastly at 12-months post-implant. Downloadable pump operations data will include evaluation of suction events, low flow and other adventitious alarms, PI events and incidence of power cable disconnects beyond 20 seconds. The previously mentioned data will also be collected during any unplanned office visits, any admission regardless of the reason, unplanned ER visits related to equipment problems or any serious adverse event-related ER visits.
UC Cleveland Medical Center
Obtain demographic and clinical data prior to and following implantation of a HeartMate 3 ® device. HeartMate 3® downloaded pump operations data will be obtained at the following scheduled intervals: discharge from the ICU, at the time of discharge from the hospital (or ± 3 days from discharge), 3-months post-implant, 6-months post-implant, and lastly at 12-months post-implant. Downloadable pump operations data will include evaluation of suction events, low flow and other adventitious alarms, PI events and incidence of power cable disconnects beyond 20 seconds. The previously mentioned data will also be collected during any unplanned office visits, any admission regardless of the reason, unplanned ER visits related to equipment problems or any serious adverse event-related ER visits.
University of Chicago
Obtain demographic and clinical data prior to and following implantation of a HeartMate 3 ® device. HeartMate 3® downloaded pump operations data will be obtained at the following scheduled intervals: discharge from the ICU, at the time of discharge from the hospital (or ± 3 days from discharge), 3-months post-implant, 6-months post-implant, and lastly at 12-months post-implant. Downloadable pump operations data will include evaluation of suction events, low flow and other adventitious alarms, PI events and incidence of power cable disconnects beyond 20 seconds. The previously mentioned data will also be collected during any unplanned office visits, any admission regardless of the reason, unplanned ER visits related to equipment problems or any serious adverse event-related ER visits.
University of Kansas Medical System
Obtain demographic and clinical data prior to and following implantation of a HeartMate 3 ® device. HeartMate 3® downloaded pump operations data will be obtained at the following scheduled intervals: discharge from the ICU, at the time of discharge from the hospital (or ± 3 days from discharge), 3-months post-implant, 6-months post-implant, and lastly at 12-months post-implant. Downloadable pump operations data will include evaluation of suction events, low flow and other adventitious alarms, PI events and incidence of power cable disconnects beyond 20 seconds. The previously mentioned data will also be collected during any unplanned office visits, any admission regardless of the reason, unplanned ER visits related to equipment problems or any serious adverse event-related ER visits.
Medical University of South Carolina
Obtain demographic and clinical data prior to and following implantation of a HeartMate 3 ® device. HeartMate 3® downloaded pump operations data will be obtained at the following scheduled intervals: discharge from the ICU, at the time of discharge from the hospital (or ± 3 days from discharge), 3-months post-implant, 6-months post-implant, and lastly at 12-months post-implant. Downloadable pump operations data will include evaluation of suction events, low flow and other adventitious alarms, PI events and incidence of power cable disconnects beyond 20 seconds. The previously mentioned data will also be collected during any unplanned office visits, any admission regardless of the reason, unplanned ER visits related to equipment problems or any serious adverse event-related ER visits.
PENDING enrollment for 9th cohort-goal is 10 sites
Obtain demographic and clinical data prior to and following implantation of a HeartMate 3 ® device. HeartMate 3® downloaded pump operations data will be obtained at the following scheduled intervals: discharge from the ICU, at the time of discharge from the hospital (or ± 3 days from discharge), 3-months post-implant, 6-months post-implant, and lastly at 12-months post-implant. Downloadable pump operations data will include evaluation of suction events, low flow and other adventitious alarms, PI events and incidence of power cable disconnects beyond 20 seconds. The previously mentioned data will also be collected during any unplanned office visits, any admission regardless of the reason, unplanned ER visits related to equipment problems or any serious adverse event-related ER visits.
PENDING enrollment for 10th cohort-goal is 10 sites
Obtain demographic and clinical data prior to and following implantation of a HeartMate 3 ® device. HeartMate 3® downloaded pump operations data will be obtained at the following scheduled intervals: discharge from the ICU, at the time of discharge from the hospital (or ± 3 days from discharge), 3-months post-implant, 6-months post-implant, and lastly at 12-months post-implant. Downloadable pump operations data will include evaluation of suction events, low flow and other adventitious alarms, PI events and incidence of power cable disconnects beyond 20 seconds. The previously mentioned data will also be collected during any unplanned office visits, any admission regardless of the reason, unplanned ER visits related to equipment problems or any serious adverse event-related ER visits.
Sponsors
Collaborators: Mayo Clinic, Medical University of South Carolina, UH, Cleveland Medical Center, University of Kansas Medical Center, Medical University of Vienna, University of Florida, University of Utah, Abbott, University of Chicago, University of California, San Francisco
Leads: International Consortium of Circulatory Assist Clinicians

This content was sourced from clinicaltrials.gov