Medical Device Network

Abbott starts new trial to assess early use benefit of HeartMate 3

The study aims to identify heart failure patients who may benefit from using the company’s HeartMate3 LVAD.

Abbott has launched a “first-of-its-kind” trial to identify advanced heart failure patients who could potentially benefit from early advanced therapy options, namely HeartMate 3 left ventricular assist device (LVAD).

The company stated that LVADs are not recommended in patients with heart failure until they are dependent on medications and have a poor prognosis, noting that earlier administration of an LVAD may provide benefit in some of these patients.

The TEAM-HF trial will enrol up to 850 patients with worsening heart failure. 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”.

The participants will be randomised to receive either a HeartMate 3 LVAD implant or continued treatment with their existing heart failure medications. The participants' pulmonary artery pressures (PAP) will be remotely monitored using Abbott's CardioMEMS HF system, implanted in a catheter-based procedure. The study will compare the improvements in PAP in both groups over two years, with a long-term follow-up option of up to five years.

"Our hope is that the TEAM-HF study will revolutionise 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."

GlobalData predicts the cardiovascular medical device market will reach $86.5bn by 2030 while the LVAD market will reach $2.24bn by 2033. Abbott’s HeartMate 3 is the current market leader in the field.

In August, the US Food and Drug Administration (FDA) expanded the label for the HeartMate3 device to eliminate the need for aspirin use as part of routine patient management. Aspirin and other blood thinners are commonly used with LVADs to reduce the risk of blood clots associated with heart pumps. The label update, exclusive for patients with an Abbott HeartMate 3 heart pump and not a class-wide approval, could improve its uptake over other LVAD devices.