Understanding the HeartMate 3 device and its impact on patients
Human/Machine Interface: What the HeartMate 3 ® Device Tells Us About the Future
International Consortium of Circulatory Assist Clinicians · NCT06039176
This study looks at how the HeartMate 3 device affects patients with advanced heart failure by checking for problems like bleeding and infection, while also seeing how it impacts their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | International Consortium of Circulatory Assist Clinicians (other) |
| Locations | 7 sites (San Francisco, California and 6 other locations) |
| Trial ID | NCT06039176 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between data from the HeartMate 3 left ventricular assist device (dLVAD) and clinical outcomes in patients with advanced heart failure. It focuses on understanding the prevalence of adverse events such as bleeding, infection, and stroke in patients receiving this device, as well as how the device's data correlates with patients' quality of life post-implantation. By analyzing pump data and clinical practices, the study seeks to improve predictions of complications and enhance patient management strategies.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are scheduled for implantation of a HeartMate 3 dLVAD.
Not a fit: Patients under 18 years of age or those scheduled for a dLVAD that is not a HeartMate 3 device may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better prediction and management of complications for patients with advanced heart failure receiving a dLVAD.
How similar studies have performed: While there have been studies on other dLVADs, this specific approach focusing on the HeartMate 3 device and its data correlation with clinical outcomes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Francisco, California and 6 other locations
- UCSF — San Francisco, California, United States (RECRUITING)
- University of Florida — Gainesville, Florida, United States (RECRUITING)
- University of Chicago — Chicago, Illinois, United States (RECRUITING)
- University of Kansas Medical Center — Kansas City, Kansas, United States (ACTIVE_NOT_RECRUITING)
- Mayo Clinic-Rochester — Rochester, Minnesota, United States (RECRUITING)
- MUSC — Charleston, South Carolina, United States (ACTIVE_NOT_RECRUITING)
- University of Utah — Salt Lake City, Utah, United States (ACTIVE_NOT_RECRUITING)
Study contacts
- Principal investigator: Sarah E Schroeder, PhD MSN RN — International Consortium of Circulatory Assist Clinicians
- Study coordinator: Sarah E Schroeder, PhD MSN RN
- Email: sarah.schroeder@vadcoordinator.org
- Phone: 402-937-3595
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: LVAD, Frailty, GI Bleed, Right Heart Failure, Infections, Hypertension, Arrhythmias, Stroke