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

NCT06039176 | Recruiting FDA Device

• 1 other identifier: ICCAC
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

LVAD; Frailty; GI Bleed; Right Heart Failure; Infections; Hypertension; Arrhythmias; Stroke

Outcome Measures

Primary Outcomes (1)

• Survival

  12-month survival post LVAD implantation stratified by percentage of abnormal pump data

  12-months

Secondary Outcomes (1)

• Variable Correlations

  12-months

Study Arms (7)

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.

Device: HeartMate 3 (R) left ventricular assist device

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.

Device: HeartMate 3 (R) left ventricular assist device

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.

Device: HeartMate 3 (R) left ventricular assist device

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.

Device: HeartMate 3 (R) left ventricular assist device

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.

Device: HeartMate 3 (R) left ventricular assist device

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.

Device: HeartMate 3 (R) left ventricular assist device

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.

Device: HeartMate 3 (R) left ventricular assist device

Interventions

HeartMate 3 (R) left ventricular assist device DEVICE

No direct intervention; this is prospective study analysis of pump data from the HeartMate 3 (R) left ventricular assist device with clinical correlation to a multitude of variables and conditions we see clinically

Mayo Clinic; Medical University of South Carolina; University of California, San Francisco; University of Chicago; University of Florida; University of Kansas Medical System; University of Utah

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The sample for this prospective study will derive of a goal of 15 individuals recruited at each of the 10 different dLVAD implanting centers, recognizing that not all sites may be able to recruit 15 participants. Participants will be selected through sequential convenience sampling, meaning each center will recruit participants in a sequential fashion in each of the centers based upon availability.

You may qualify if:

• years of age or older
• Scheduled Heartmate 3 ® dLVAD implantation

You may not qualify if:

• \<18 years of age
• Scheduled for dLVAD that is NOT a Heartmate 3 (R) device

Sponsors & Collaborators

• Mayo Clinic: collaborator
• University of Florida: collaborator
• University of Utah: collaborator
• University of Kansas Medical Center: collaborator
• Medical University of South Carolina: collaborator
• University of Chicago: collaborator
• University of California, San Francisco: collaborator
• International Consortium of Circulatory Assist Clinicians: lead
• Abbott: collaborator
• Medical University of Vienna: collaborator

Study Sites (7)

UCSF

San Francisco, California, 94143, United States

RECRUITING

University of Florida

Gainesville, Florida, 32611, United States

RECRUITING

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, 66103, United States

ACTIVE NOT RECRUITING

Mayo Clinic-Rochester

Rochester, Minnesota, 55902, United States

RECRUITING

MUSC

Charleston, South Carolina, 29425, United States

ACTIVE NOT RECRUITING

University of Utah

Salt Lake City, Utah, 84112, United States

ACTIVE NOT RECRUITING

Related Publications (14)

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  PMID: 30700139 RESULT

• Shahim B, Kapelios CJ, Savarese G, Lund LH. Global Public Health Burden of Heart Failure: An Updated Review. Card Fail Rev. 2023 Jul 27;9:e11. doi: 10.15420/cfr.2023.05. eCollection 2023.

  PMID: 37547123 RESULT

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  PMID: 17435073 RESULT

• Gosev I, Kiernan MS, Eckman P, Soleimani B, Kilic A, Uriel N, Rich JD, Katz JN, Cowger J, Lima B, McGurk S, Brisco-Bacik MA, Lee S, Joseph SM, Patel CB; Evolving Mechanical Support Research Group (EMERG) Investigators. Long-Term Survival in Patients Receiving a Continuous-Flow Left Ventricular Assist Device. Ann Thorac Surg. 2018 Mar;105(3):696-701. doi: 10.1016/j.athoracsur.2017.08.057. Epub 2017 Dec 2.

  PMID: 29198630 RESULT

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  PMID: 26065994 RESULT

• Mehra MR, Goldstein DJ, Uriel N, Cleveland JC Jr, Yuzefpolskaya M, Salerno C, Walsh MN, Milano CA, Patel CB, Ewald GA, Itoh A, Dean D, Krishnamoorthy A, Cotts WG, Tatooles AJ, Jorde UP, Bruckner BA, Estep JD, Jeevanandam V, Sayer G, Horstmanshof D, Long JW, Gulati S, Skipper ER, O'Connell JB, Heatley G, Sood P, Naka Y; MOMENTUM 3 Investigators. Two-Year Outcomes with a Magnetically Levitated Cardiac Pump in Heart Failure. N Engl J Med. 2018 Apr 12;378(15):1386-1395. doi: 10.1056/NEJMoa1800866. Epub 2018 Mar 11.

  PMID: 29526139 RESULT

• Milano CA, Rogers JG, Tatooles AJ, Bhat G, Slaughter MS, Birks EJ, Mokadam NA, Mahr C, Miller JS, Markham DW, Jeevanandam V, Uriel N, Aaronson KD, Vassiliades TA, Pagani FD; ENDURANCE Investigators. HVAD: The ENDURANCE Supplemental Trial. JACC Heart Fail. 2018 Sep;6(9):792-802. doi: 10.1016/j.jchf.2018.05.012. Epub 2018 Jul 11.

  PMID: 30007559 RESULT

• Birks EJ. Stopping LVAD Bleeding: A Piece of the Puzzle. Circ Res. 2017 Sep 29;121(8):902-904. doi: 10.1161/CIRCRESAHA.117.311759. No abstract available.

  PMID: 28963184 RESULT

• Zinoviev R, Lippincott CK, Keller SC, Gilotra NA. In Full Flow: Left Ventricular Assist Device Infections in the Modern Era. Open Forum Infect Dis. 2020 Apr 17;7(5):ofaa124. doi: 10.1093/ofid/ofaa124. eCollection 2020 May.

  PMID: 32405511 RESULT

• Cornwell WK 3rd, Ambardekar AV, Tran T, Pal JD, Cava L, Lawley J, Tarumi T, Cornwell CL, Aaronson K. Stroke Incidence and Impact of Continuous-Flow Left Ventricular Assist Devices on Cerebrovascular Physiology. Stroke. 2019 Feb;50(2):542-548. doi: 10.1161/STROKEAHA.118.022967. No abstract available.

  PMID: 30602359 RESULT

• Kilic A, Macickova J, Duan L, Movahedi F, Seese L, Zhang Y, Jacoski MV, Padman R. Machine Learning Approaches to Analyzing Adverse Events Following Durable LVAD Implantation. Ann Thorac Surg. 2021 Sep;112(3):770-777. doi: 10.1016/j.athoracsur.2020.09.040. Epub 2020 Nov 20.

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• Watson AR, Wah R, Thamman R. The Value of Remote Monitoring for the COVID-19 Pandemic. Telemed J E Health. 2020 Sep;26(9):1110-1112. doi: 10.1089/tmj.2020.0134. Epub 2020 May 7.

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Related Links

• AHA: Advanced Heart Failure
• G\*Power Statistical Power Analyses for Mac and Window
• Adverse Event Definitions

MeSH Terms

Conditions

Frailty; Gastrointestinal Hemorrhage; Heart Failure; Infections; Hypertension; Arrhythmias, Cardiac; Stroke

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Sarah E Schroeder, PhD MSN RN

  International Consortium of Circulatory Assist Clinicians

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah E Schroeder, PhD MSN RN

CONTACT

402-937-3595; sarah.schroeder@vadcoordinator.org

Thomas Schloglhofer, MSc

CONTACT

+43 650 7119129; thomas.schloeglhofer@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 15, 2023
• Study Start: October 27, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

US (7)