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Human/Machine Interface: What the HeartMate 3 ® Device Tells Us About the Future
NCT06039176 · View on ClinicalTrials.gov ↗
Study 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 fo
Conditions Studied
Interventions
- DEVICE HeartMate 3 (R) left ventricular assist device
Study Locations (7)
California
- UCSF — San Francisco
Florida
- University of Florida — Gainesville
Illinois
- University of Chicago — Chicago
Kansas
- University of Kansas Medical Center — Kansas City
Minnesota
- Mayo Clinic-Rochester — Rochester
South Carolina
- MUSC — Charleston
Utah
- University of Utah — Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2023-10-27 |
| Est. Completion | 2026-12-30 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06039176
The ClinicalTrials.gov registry entry for NCT06039176 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is International Consortium of Circulatory Assist Clinicians, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 8 conditions, with Hypertension appearing as the primary indexed condition, and to 1 intervention — of which HeartMate 3 (R) left ventricular assist device is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06039176 reports 7 study locations spanning 7 distinct geographic areas — top geographies include California, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06039176 about?
NCT06039176 is a clinical study titled "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 ...
What is the current status of trial NCT06039176?
This trial is currently recruiting. The enrollment target is 150 participants. The study started on 2023-10-27. Estimated completion is 2026-12-30.
What conditions does trial NCT06039176 study?
This clinical trial studies the following conditions: Hypertension, Stroke, Frailty, Infections, Right Heart Failure. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06039176?
The interventions under investigation include: HeartMate 3 (R) left ventricular assist device (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06039176?
This trial is sponsored by International Consortium of Circulatory Assist Clinicians, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06039176 being conducted?
This trial has 7 study locations across California, Florida, Illinois, Kansas, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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