Evaluation of the Cordella Pulmonary Artery Sensor System for Safety and Effectiveness in Adults with NYHA Class II and III Heart Failure

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the Cordella Pulmonary Artery Sensor System in adults with New York Heart Association NYHA Class II and III heart failure. This multi-center, open-label, randomized controlled trial aims to assess how well this device helps manage heart failure by providing daily pulmonary artery pressure PAP measurements to clinicians and patients. The study includes multiple groups to compare different management strategies and patient self-management approaches. Participants will receive the Cordella Sensor device, which measures and transmits daily PAP data along with other vital signs such as blood pressure, weight, heart rate, and oxygen saturation. Clinicians will manage patients heart failure therapy based on these data using guideline-directed medical therapy. Some participants will follow a clinician-directed patient self-management plan involving daily PAP measurement and medication adjustments. The trial includes several study arms for both NYHA Class II and III cohorts, with some participants potentially crossing over between groups after a period. During the study, participants will take daily measurements using the Cordella system and attend scheduled follow-up visits. Researchers will monitor heart failure events, hospitalizations, mortality, device safety, and pressure sensor performance over months to years. The primary outcomes include heart failure events or cardiovascular death at 6 to 24 months, and safety outcomes related to device complications and sensor failure. Secondary outcomes cover hospitalization rates, medication changes, quality of life, functional status, and economic analyses. Participants are expected to comply with device use and follow-up visits throughout the trial duration, which may extend up to five years.

PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III