Cordella Pulmonary Artery Sensor System to Reduce Heart Failure Hospitalizations
PROACTIVE-HF-2 is a multi-center study evaluating the Cordella™ Pulmonary Artery (PA) Sensor System in patients with chronic heart failure (NYHA Class II–III). The trial includes a randomized controlled component and a single-arm component to assess different strategies for using PA pressure data to guide outpatient HF care. Adult patients with a documented history of heart failure for at least 3 months who remain symptomatic (NYHA II–III), are on guideline-directed medical therapy, and meet biomarker and diuretic-treatment criteria are eligible if they can operate the myCordella Patient Reader and have sufficient home internet coverage. Key exclusion criteria include refractory Stage D HF, recent major cardiovascular events, severe valvular or congenital heart disease, known coagulation disorders or hypersensitivity to required antiplatelet therapy, severe comorbidity limiting survival to less than two years, or participation in another investigational trial. The implanted PA sensor continuously measures pulmonary artery pressures; clinicians receive data to inform timely adjustments in therapy aimed at reducing decompensations. Primary endpoints focus on heart failure events, HF hospitalizations, and device safety assessed through 24 months. Secondary endpoints include all-cause and cardiovascular mortality, changes in functional status and quality of life, and economic/resource utilization measured over the longer follow-up. Participants undergo baseline implantation and scheduled follow-ups with remote monitoring plus in-person visits at baseline and at 12, 24, 36, 48, and 60 months, with study duration up to 60 months. The study evaluates whether remote PA pressure-guided management using the Cordella system reduces HF hospitalizations and is safe and cost-effective in this population.