HeartMate 3 Device for Heart Failure
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how the HeartMate 3® device, a heart pump for severe heart failure, affects daily life. Researchers aim to understand how data from the device, such as alarms and alerts, relate to quality of life and potential health issues. They will collect data from participants' devices at various intervals after implantation, including post-hospital discharge and at 3, 6, and 12 months. This trial suits adults scheduled to receive the HeartMate 3® device. As a Phase 4 trial, this research provides insights into how the FDA-approved HeartMate 3® benefits more patients and impacts daily life.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that the HeartMate 3 ® dLVAD is safe for patients with advanced heart failure?
Research shows that most patients generally tolerate the HeartMate 3 device well. In earlier studies, some individuals experienced issues like interruptions in the device's flow and the pump stopping, occurring in about 21% and 9.2% of cases, respectively. Serious side effects, such as strokes, major infections, and bleeding, can occur but vary among individuals. Another study found that one patient did not experience further problems after initial adjustments. The FDA has approved the HeartMate 3 for other conditions, indicating it has passed safety checks for those uses as well. It's important to remember that every medical device carries risks, but many people have used the HeartMate 3 successfully.12345
Why are researchers excited about this trial?
Researchers are excited about the HeartMate 3® device because it offers a new level of interaction between human and machine in managing heart failure. Unlike traditional heart pumps, HeartMate 3® provides detailed operational data that can be downloaded and analyzed, offering insights into suction events, low flow alarms, and other critical pump functions. This real-time monitoring feature could enhance patient care by allowing doctors to make more informed decisions and address issues promptly. Additionally, the device's advanced design aims to reduce complications like pump thrombosis, making it a promising alternative to existing heart assist devices.
What evidence suggests that the HeartMate 3® dLVAD is effective for improving quality of life in advanced heart failure patients?
Research has shown that the HeartMate 3 device holds promise for people with severe heart failure. Earlier studies found the device effective 94% of the time after one year and 80% after five years. Another study demonstrated that people using the HeartMate 3 had similar two-year survival rates to younger patients who received heart transplants. The device provides long-term support and effectively reduces heart failure symptoms. Overall, it offers a reliable and effective treatment for those unable to undergo heart transplants.24567
Who Is on the Research Team?
Sarah E Schroeder, PhD MSN RN
Principal Investigator
International Consortium of Circulatory Assist Clinicians
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Post-Implantation Monitoring
Monitoring of HeartMate 3® dLVAD pump operations data at various intervals post-implantation
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- HeartMate 3
How Is the Trial Designed?
7
Treatment groups
Experimental Treatment
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.
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.
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.
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.
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
International Consortium of Circulatory Assist Clinicians
Lead Sponsor
Wake Forest University Health Sciences
Collaborator
University of California, San Francisco
Collaborator
University of Florida
Collaborator
Abbott
Industry Sponsor
Dr. Etahn Korngold
Abbott
Chief Medical Officer
MD, Harvard Medical School
Robert B. Ford
Abbott
Chief Executive Officer since 2020
Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business
Medical University of Vienna
Collaborator
Mayo Clinic
Collaborator
University of Kansas Medical Center
Collaborator
Advocate Health Care
Collaborator
University of Utah
Collaborator
Citations
HeartMate 3: Analysis of Outcomes and Future Directions
This review provides a comprehensive synthesis of the safety and efficacy of the 2-year and 5-year HeartMate LVAD outcomes, highlighting key findings.
Ten-year report on the first patient with HeartMate 3 left ...
The HeartMate 3 has proved to be the most advanced assist device of the last decade. It has provided effective and reliable long-term support ...
SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)
Results demonstrated that the. HeartMate 3 LVAD achieved. 94% reliability with 90% confidence at one year and. 80% reliability with 80% confidence at 5 years.
New Analysis Shows LVAD Therapy Offers Similar Survival ...
A recent comparative analysis of data from the MOMENTUM 3 trial and UNOS registry found two-year survival rates were the same among younger heart failure ...
HeartMate 3: Analysis of Outcomes and Future Directions
This review provides a comprehensive synthesis of the safety and efficacy of the 2-year and 5-year HeartMate LVAD outcomes, highlighting key findings.
6.
cardiovascular.abbott
cardiovascular.abbott/us/en/hcp/products/heart-failure/left-ventricular-assist-devices/heartmate-3/indications-safety-warnings.htmlHeartMate 3 LVAD Indications, Safety and Warnings
Adverse Events: Adverse events that may be associated with the use of the HeartMate 3 Left Ventricular Assist System are: death, bleeding, cardiac arrhythmia, ...
Adverse events with HeartMate-3 Left ventricular assist ...
The most common device events reported were infusion flow disruptions (21%), halted pump (9.2%), and material deformation (8.4%) (Fig. 1A). Additionally, of the ...
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