St Jude Medical has started enrollment in its LAPTOP-HF (Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy) study. The study is designed to demonstrate that the new investigational left atrial pressure (LAP) management system improves outcomes in patients with heart failure (HF).
St Jude Medical said that the system allows patients to adjust their HF medications daily based on a physician-directed prescription plan and their current LAP, similar to the manner in which diabetes patients manage their insulin therapy.
The LAPTOP-HF trial is a 700 patient pivotal, randomized, controlled, prospective, multi-center clinical investigation to evaluate the safety and effectiveness of the LAP HF management system. Currently, there is no means of measuring LAP outside the hospital setting.
According to the study, patients participating in the LAPTOP-HF trial, who receive the implantable sensor, will be given a portable, handheld device that wirelessly retrieves the LAP measurement data from the implanted sensor. The system’s DynamicRx feature then directs patients to adjust their medications based on the physician’s prescription plan.
St Jude Medical said that the LAP management system is being studied under an investigational device exemption (IDE) from the FDA.
Mark Carlson, chief medical officer and senior vice president of research and clinical affairs of cardiac rhythm management division at St Jude Medical, said: “If successful, this trial will provide physicians with a valuable tool to treat heart failure more efficiently and more effectively, providing patients with better quality of life and reducing burden on the health care system. This is just one of the many technologies St Jude Medical is focused on developing to improve physicians’ and patients’ ability to manage this chronic disease.”