Abbott initiates new clinical trial to improve outcomes in patients with advanced Heart Failure
Abbott Park, Ill.: Abbott has announced a new, first-of-its-kind clinical trial designed to improve outcomes in patients with worsening heart failure who could benefit from advanced therapy options. The TEAM-HF trial, which is planned to enroll up to 850 patients across 75 sites worldwide, will measure pulmonary artery pressures (PAP) using Abbott's CardioMEMS HF System to objectively identify advanced heart failure patients at high risk of mortality who could benefit from a life-saving HeartMate 3 left ventricular assist device (LVAD, or heart pump) earlier in their disease progression.
Heart failure is a progressive condition that occurs when the heart can't circulate blood efficiently, resulting in symptoms such as fatigue, breathlessness, and swollen ankles. Approximately 6.7 million people in the United States have heart failure, and that number is expected to rise to 8.5 million by 2030. While there are currently evidence-based guidelines for treating patients with advanced therapies (either LVADs or heart transplantation) when they are in end-stage heart failure, there are fewer objective criteria for identifying patients who are earlier in their disease progression. This can result in patients being offered advanced therapies such as an LVAD when their heart failure has become too advanced, leading to poorer outcomes, and even death.
"The goal of the TEAM-HF trial is simple in concept but critical to the future care of patients. We want to break down patient care silos, offering a unified effort to not only improve the diagnosis of advanced heart failure, but also enable rapid access to life saving heart pumps. This study aims to take the guess work out of deciding when a patient has reached the ideal time for LVAD implementation," said Jennifer Cowger, M.D., medical director of mechanical circulatory support and section head of the advanced heart failure program at Detroit-based Henry Ford Health, and one of the national co-principal investigators for the TEAM-HF trial. "Too many patients are not receiving timely access to this life-saving therapy and are needlessly dying of heart failure. The importance of patient access to multidisciplinary heart failure care is embodied in the trial acronym - TEAM-HF - and we feel this study will be instrumental in helping providers identify patients who may benefit from a heart pump earlier in their care journey."
