Wednesday, July 14, 2010

URMC Studying Heart Device

Cardiologists at the University of Rochester Medical Center (URMC) are enrolled in a clinical trial to study how technology can help congestive heart failure patients. The technology will help patients and their doctors to more closely monitor heart health status on a daily basis and could potentially impact the progression of heart failure.

Currently physician’s care decisions are guided primarily by patient-reported symptoms such as breathlessness, reduced exercise capacity, swelling of the ankles, fatigue and weakness. Using these red flags, a diagnosis can be made regarding worsening heart failure and may prompt a change in medication dosage. Often by the time symptoms become obvious, the patient needs to be hospitalized.

The Left Atrial Pressure Monitoring to Optimize Health Failure (LAPTOP-HF) therapy is sponsored by St. Jude Medical. The trial is a pivotal, randomized controlled, prospective, multi-center clinical investigation to evaluate the safety and effectiveness of the company’s implantable Left Atrial Pressure (LAP) heart failure management system. The system is being studied under an investigational device exemption from FDA.

The system includes:

• A small pacemaker-size, stand-alone, implantable LAP monitoring device, or a cardiac rhythm management device with an integrated LAP monitoring device
• A lead or thin wire from the device to the heart with an LAP sensor
• Patient Advisor Module ®, a portable wireless, hand-held device used by the patient to check LAP status and through the DynamicRx® feature. Then the patient is directed to take specific medicines or make lifestyle adjustments based on the LAP measurement

The trial is expected to enroll about 700 patients at up to 75 centers across the U.S. URMC was the first center to implant the technology last September as part of a feasibility trial and is also the first center to participate in this current phase of the study.

The study will consist of New York Heart Association Class III patients with a history of ischemic or non-ischemic cardiomyopathy for at least six months and at least one heart failure hospitalization within the past 12 months.

The volunteers are randomized to a treatment group to receive the implantable sensor along with the hand-held device that wirelessly collects data from the LAP sensor and provides information. Medication recommendations go from the physician directly to the patient or to a control group that receives standard heart failure therapy.

Cardiac electrophysiologist Spenser Z. Rosero, M.D., Associate Professor of Medicine at URMC and Director of the Hereditary Arrhythmia Clinic, and Leway Chen, M.D. Associate Professor of Medicine and Director of the Program in Heart Failure and Transplantation are leading the study.