Abbott has announced the commencement of a new clinical trial for its advanced left ventricular assist device (LVAD), the HeartMate 3, to determine the benefits of early implantation of the device in patients with advanced heart failure.
In a press release announcing the trial, Abbott said the trial is a “first-of-its-kind” to identify advanced heart failure patients who could potentially benefit from early advanced therapy options, the HeartMate 3 in this case.
While traditionally reserved for patients awaiting a heart transplant who may be dependent on medications (including IV-administered heart failure medications for end-stage heart failure) and/or too ill for other surgical options, HeartMate 3 has become a mainstay in supporting patients with advanced heart failure, significantly improving their quality of life and, in many cases, extending survival rates.
The study aims to see whether the HeartMate 3 can be used as an early intervention option, and not just in last-resort cases. Abbott is hopeful that earlier administration of an LVAD may offer benefit to patients with advanced heart failure.
Up to 850 patients with worsening heart failure will be enrolled across 75 sites worldwide in the TEAM-HF trial, explained Abbott. The study’s trial investigator noted that “the study aims to take the guesswork out of deciding when a patient has reached the ideal time for LVAD implementation.”
Heart failure is a progressive condition in which the heart cannot pump blood efficiently, leading to symptoms like fatigue, breathlessness and swollen ankles. In the US, an estimated 6.7 million people are affected by heart failure, with that number projected to increase to 8.5 million by 2030.
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Although evidence-based guidelines exist for advanced therapies, such as LVADs or heart transplantation, in end-stage heart failure, there are fewer standardized criteria for identifying patients in earlier stages of the disease. This lack of early intervention guidance means patients often receive advanced therapies, like an LVAD, only once their condition has become too severe, which can lead to worse outcomes and even death.
Participants in the study will be randomized to receive either a HeartMate 3 LVAD implant or continue with their current heart failure medications, explained Abbott.
The trial will take an innovative approach to evaluate the benefits of earlier intervention in patients with worsening heart failure by monitoring pulmonary artery pressures (PAP) as a primary endpoint.
PAPs will be measured remotely using Abbott’s CardioMEMS HF system, which is implanted in a minimally invasive catheter-based procedure in a pulmonary artery. The device tracks PAP changes over time.
If PAP levels do not decrease with guideline-directed medical therapy, the trial will aim to demonstrate that these patients could benefit from advanced therapies. These patients will then be randomly assigned to receive either the HeartMate 3 LVAD implant or continue with their existing medications.
Those whose medications successfully reduce their PAP levels will join a single-arm registry and continue to be managed based on real-time data from their CardioMEMS sensor.
The study will track PAP improvements in both groups over a two-year period, with the option of long-term follow-up for up to five years.
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Heart failure affects about 6.5 million people in the US, and it is estimated that by 2030, this number will exceed 8 million. It is also estimated that there are 960,000 new heart failure cases each year.
LVADs have long been a lifeline for patients in the most critical stages of heart failure, but expanding the use of such devices to those with less severe, albeit progressive, heart failure could change the course of treatment.
The HeartMate 3 is a next-generation LVAD, a type of heart pump designed to support the heart’s function by taking on the task of circulating blood when the heart is unable to do so effectively.
Unlike traditional LVADs, the HeartMate 3 utilizes advanced magnetic levitation (MagLev) flow technology, which reduces the risk of pump thrombosis and blood cell damage, two common complications associated with older-generation LVADs. Additionally, its compact design and advanced engineering allow for quieter and more efficient performance, making it a more comfortable and reliable option for patients.
“Our hope is that the TEAM-HF study will revolutionize care management for these patients and their families. Getting people on a heart pump more quickly could mean more time spent out of the hospital and with loved ones,” said Keith Boettiger, vice president of Abbott’s Heart Failure business.
“By having more objective methods to accurately gauge heart failure progression and refer people to receive this life-saving therapy faster, healthcare experts will be able to provide patients with improved survival rates and quality of life based on the anticipated results of the TEAM-HF study.”
Abbott’s HeartMate 3 is currently the leader in the cardiovascular medical device market.
According to GlobalData, the market is expected to reach a value of $86.5 billion by 2030 while the LVAD market will hit $2.24 billion by 2033.
In August, the US Food and Drug Administration (FDA) updated the label for the HeartMate 3 device, removing the requirement for routine aspirin use in patient management.
Blood thinners like aspirin are typically prescribed with LVADs to reduce clotting risks associated with heart pumps. This label change, specific to patients using the Abbott HeartMate 3 and not applicable to other LVADs, may boost its preference over competing devices.
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