St. Jude Medical commences enrollment in LAPTOP-HF study

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the first enrollment in its LAPTOP-HF (Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy) study. The goal of the LAPTOP-HF study is to demonstrate that the new investigational left atrial pressure (LAP) management system safely and effectively improves outcomes in patients with heart failure (HF). 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.

“This system has the potential to bring left atrial pressure monitoring to the outpatient setting, which I believe will ultimately empower patients to take more control in the management of their condition.”

Clinicians commonly use the symptoms of HF, such as fatigue or shortness of breath, to determine a patient's HF status and subsequent treatment; however, changes in HF symptoms are difficult to gauge and may be caused by other conditions. LAP is considered the "gold standard" for assessing HF status, providing the most objective measure of left-sided hemodynamics. Changes in LAP precede development of pulmonary edema (fluid in the lungs) and result in worsening HF symptoms.

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.

The first enrollment was performed by a multidisciplinary team including the Principal Investigators, Dr. Leway Chen, a heart failure specialist, and Dr. Spencer Rosero, a cardiac electrophysiologist, both from the University of Rochester Medical Center in Rochester, New York. Commenting on the trial, Dr. Chen said, "This system has the potential to bring left atrial pressure monitoring to the outpatient setting, which I believe will ultimately empower patients to take more control in the management of their condition." Dr. Rosero said, "The initiation of this trial is an important step towards the real-time management of chronic diseases and improving the lives of those living with heart failure."

Physician-directed, patient self-management, which has become standard in diabetes management, is a new approach for HF management. It may provide physicians the ability to better personalize and optimize HF management on the basis of daily, objective measures of a patient's HF status. By providing patients with daily feedback on their LAP status and automated prescription instructions, it may also encourage self-management and treatment adherence in a more efficient manner than possible with traditional heart failure management approaches.

Recently published results of the HOMEOSTASIS feasibility clinical study suggest that use of outpatient LAP monitoring, with patient-managed therapy, could change current management of advanced heart failure, facilitate more optimal therapy and improve patient outcomes.

"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," said Dr. Mark Carlson, chief medical officer and senior vice president of research and clinical affairs for the St. Jude Medical Cardiac Rhythm Management Division. "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."