NCT06039176 Human/Machine Interface: What the HeartMate 3 ® Device Tells Us About the Future
| NCT ID | NCT06039176 |
| Status | Recruiting |
| Phase | — |
| Sponsor | International Consortium of Circulatory Assist Clinicians |
| Condition | LVAD |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2023-10-27 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2023-10-27 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Sarah E Schroeder, PhD MSN RN
PRINCIPAL INVESTIGATOR
International Consortium of Circulatory Assist Clinicians
Frequently Asked Questions
Who can join the NCT06039176 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying LVAD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06039176 currently recruiting?
Yes, NCT06039176 is actively recruiting participants. Contact the research team at sarah.schroeder@vadcoordinator.org for enrollment information.
Where is the NCT06039176 trial being conducted?
This trial is being conducted at San Francisco, United States, Gainesville, United States, Chicago, United States, Kansas City, United States and 3 additional locations.
Who is sponsoring the NCT06039176 clinical trial?
NCT06039176 is sponsored by International Consortium of Circulatory Assist Clinicians. The principal investigator is Sarah E Schroeder, PhD MSN RN at International Consortium of Circulatory Assist Clinicians. The trial plans to enroll 150 participants.