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NCT06039176
Human/Machine Interface: What the HeartMate 3 ® Device Tells Us About the Future
trial testing HeartMate 3 (R) left ventricular assist device in LVAD in 150 participants. Currently enrolling.
30 December 2026
Quick facts
| Lead sponsor | International Consortium of Circulatory Assist Clinicians |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 150 |
| Start date | 27 October 2023 |
| Primary completion | 30 December 2026 |
| Estimated completion | 30 December 2026 |
| Sites | 7 locations across United States |
Drugs / interventions tested
- HeartMate 3 (R) left ventricular assist device
Conditions studied
- LVAD — all drugs for LVAD →
- Frailty — all drugs for Frailty →
- GI Bleed — all drugs for GI Bleed →
- Right Heart Failure — all drugs for Right Heart Failure →
Sponsor
International Consortium of Circulatory Assist Clinicians
Who can join
Adults 18 to 100, any sex, with LVAD or Frailty. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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. 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06039176
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Related trials
Other recruiting trials for LVAD
Currently open trials in the same condition.
- NCT07034599 — Effects of Negative Pressure Ventilation Onto Hemodynamics and Right Ventricular Funktion in Patients After Implantation · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06039176 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by International Consortium of Circulatory Assist Clinicians
- Last refreshed: 16 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06039176.
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