Rationale and Design of the Proactive-HF Trial for Managing Patients With NYHA Class III Heart Failure by Using the Combined Cordella Pulmonary Artery Sensor and the Cordella Heart Failure System

•The PROACTIVE-HF trial is designed to assess the benefit of personalized and proactive management of patients with class III heart failure (HF) guided by daily measurements of pulmonary artery pressure (PAP) pressures in combination with weight, blood pressure, heart rate, blood oxygen saturation, and symptoms.•The investigational Cordella Sensor System is designed to achieve high levels of patient engagement and compliance by the use of a small hand-held reader placed over an anteriorly implanted sensor, facilitating patient-friendly seated PAP measurements and a modern digital health app providing patients with timely education, real-time feedback and tools for easy 2-way communication with the care providers.•Key trial hypotheses are that HF management using PAP in combination with additional vital-sign parameters will provide the dual benefits of congestion management and GDMT optimization and that patient engagement and compliance will positively impact remote medical management decisions and patient outcomes. Optimizing guideline-directed medical therapy (GDMT) and monitoring congestion in patients with heart failure (HF) are key to disease management and preventing hospitalizations. A pulmonary artery pressure (PAP)-guided HF management system providing access to body weight, blood pressure, heart rate, blood oxygen saturation, PAP, and symptoms, may provide new insights into the effects of patient engagement and comprehensive care for remote GDMT titration and congestion management. The PROACTIVE-HF study was originally approved in 2018 as a prospective, randomized, controlled, single-blind, multicenter trial to evaluate the safety and effectiveness of the Cordella PAP Sensor in patients with HF and with New York Heart Association (NYHA) functional class III symptoms. Since then, robust clinical evidence supporting PAP-guided HF management has emerged, making clinical equipoise and enrolling patients into a standard-of-care control arm challenging. Therefore, PROACTIVE-HF was changed to a single-arm trial in 2021 with prespecified safety and effectiveness endpoints to provide evidence for a similar risk/benefit profile as the CardioMEMS HF System. The single-arm PROACTIVE-HF trial is expected to further demonstrate the benefits of PAP-guided HF management of patients with NYHA class III HF. The addition of vital signs, patient engagement and self-reported symptoms may provide new insights into remote GDMT titration and congestion management.