Abbott has announced the launch of the TEAM-HF clinical trial, a pioneering study designed to improve outcomes for patients with worsening heart failure. The trial will utilize AI and Abbott’s CardioMEMS™ HF System to identify patients who may benefit from earlier intervention with advanced therapies, such as a HeartMate 3™ left ventricular assist device (LVAD).
Addressing Advanced Heart Failure
Heart failure is a progressive condition affecting millions globally. While guidelines exist for treating end-stage heart failure with advanced therapies, identifying patients who could benefit from earlier intervention remains a significant challenge, often leading to delayed treatment and poorer outcomes.
TEAM-HF: A Novel Approach
The TEAM-HF trial will enroll up to 850 patients across 75 sites globally. The trial employs a novel approach to guide treatment decisions:
- AI-Powered Monitoring: Abbott’s CardioMEMS™ HF System, an implantable sensor that monitors pulmonary artery pressure (PAP), will provide continuous data on heart function.
- Early Intervention: Patients whose PAP levels do not improve with medication will be randomized to receive either a HeartMate 3™ LVAD or continued medical therapy.
- Personalized Treatment: Patients whose PAP levels respond to medication will be managed based on their CardioMEMS™ data.
Trial Enrollment and Evaluation
Enrollment in TEAM-HF will commence shortly at sites across the U.S. The trial’s powered primary and secondary endpoints will be evaluated at two years, with long-term follow up through five years.
"As the only healthcare company in the world that has developed medical devices designed to treat people at each stage of heart failure, 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, 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."
