Abbott has announced a new clinical trial of its CardioMEMS HF System, which aims to improve outcomes in patients with advanced heart failure.
The TEAM-HF trial will measure pulmonary artery pressures (PAP) using Abbott’s CardioMEMS HF System. It will enrol up to 850 patients at 75 sites globally.
This approach will help identify advanced heart failure patients at high risk of mortality. These patients may benefit from the HeartMate 3 left ventricular assist device (LVAD) earlier in their disease progression.
In August 2021, Abbott announced positive results from the GUIDE-HF clinical trial. This 1,000-patient randomised study evaluated the benefits of the CardioMEMS HF System for individuals with NYHA Class II, III, and IV heart failure.
In 2022, the US Food and Drug Administration (FDA) approved an expanded indication of the system for earlier-stage heart failure.
Additionally, last year, the healthcare technology firm announced positive data for the CardioMEMS HF System from the MONITOR-HF trial.
The TEAM-HF trial will use a new approach to evaluate early interventions for patients with worsening heart failure.
Researchers will analyse PAP data collected securely from participants using Abbott’s CardioMEMS HF System.
This sensor, implanted in the pulmonary artery during a minimally invasive procedure, tracks pulmonary artery pressure changes over time.
If PAP levels remain high despite guideline-directed medical therapy, the trial will explore the benefits of advanced treatments.
Participants will be randomised to receive either the HeartMate 3 LVAD implant or to continue their current heart failure medications.
Those whose medications effectively lower PAP will enter a single-arm registry, where they will be managed based on data from their CardioMEMS sensor.
Abbott heart failure business vice president Keith Boettiger said: “Getting people on a heart pump more quickly could mean more time spent out of the hospital and with loved ones.
“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.”
Enrolment for the trial will begin soon at various sites across the US. The primary and secondary endpoints of the trial will be assessed at two years, with long-term follow-up extending to five years.
