Study of the CardioMEMS HF System to Improve Heart Failure Outcomes Using Pulmonary Artery Pressure Monitoring

What this Trial Is About

Researchers are evaluating whether managing heart failure patients using the CardioMEMS HF System, which monitors pulmonary artery PA pressure, improves long-term health outcomes compared to usual care without PA pressure monitoring. This observational study focuses on heart failure patients and aims to determine the impact on hospitalization rates and survival over two years in a real-world setting. Abbott Medical Devices leads this research to better understand the benefits of PA pressure-guided management. Participants include heart failure patients either implanted with the CardioMEMS PA pressure sensor or managed without PA pressure monitoring as a control group. The study compares two groups those with the device and those without it. The CardioMEMS HF System continuously monitors PA pressure to guide heart failure management decisions. During the study, researchers will track heart failure hospitalizations and overall survival for two years. They will review hospitalization rates related to heart failure and survival from any cause to assess differences between the groups. Participants will be monitored regularly, and their health outcomes will be recorded to evaluate the effectiveness of PA pressure-guided management over standard care.

CardioMEMS HF System Coverage With Evidence Development Study