Sentara Cardiovascular Research Institute Investigates System Designed as Early Warning for Heart Failure Patients
Researchers at Sentara Cardiovascular Research Institute are among top enrollers at 69 leading heart centers in the U.S. involved in a clinical trial designed to investigate a new device to evaluate the safety and efficacy of a physician-directed patient self management system.
The purpose is to determine if an implantable device, smaller than a smart phone, can effectively monitor the pressure in the left atrium of the heart, and manage the patient's medications to reduce episodes of heart failure.
Clinicians commonly use the symptoms of heart failure such as fatigue or shortness of breath to determine a heart failure patient's status and need for treatment. Left atrial pressure is considered an excellent indicator of status, providing the most objective measure. Changes in left atrial pressure occur before fluid retention and worsening of heart failure symptoms.
In this research study, the device is implanted just under the skin in the chest with wires connected to the heart in half of the study patients. This device records left atrial pressure, and a hand-held monitor collects that information, transmits the information to doctors and nurses at the study center over regular phone lines, and directs patients to take medicines or make lifestyle changes as needed. The study is designed to ask patients to increase heart failure medicines to relieve symptoms before they occur.
The Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy (LAPTOP-HF) is a randomized, controlled study sponsored by medical device company St. Jude Medical. For more information about the study and eligibility, visit www.clinicaltrials.gov . The study identifier is NCT01121107.
About Sentara. Sentara Healthcare is one of the nation's leading not-for-profit health systems, acknowledged as a leader in patient safety and quality innovation. For more information about Sentara or Sentara Cardiovascular Research Institute, visit www.sentara.com.