Abbott initiates clinical trial of its CardioMems in advanced heart failure

Abbott (ABT) 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 earlier in their disease progression. The TEAM-HF trial will deploy a novel approach to assess the impact of earlier interventions in patients with worsening heart failure. The CardioMEMS sensor, placed in the pulmonary artery during a minimally invasive outpatient procedure, monitors pulmonary artery pressure changes over time. If pressures do not go down with guideline directed medical therapy, the TEAM-HF trial will seek to prove that such patients will benefit from advanced therapies. 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.