A new clinical trial at Virginia Commonwealth University is studying the safety and effectiveness of a new device for patients diagnosed with moderate to severe heart failure. VCU is one of approximately 30 clinical sites in North America participating in the study.
Heart failure is a common condition affecting more than 5 million people of all ages in the United States. Each year, 500,000 new cases are reported and the disease is responsible for more than 1 million hospitalizations.
Currently, there is no cure for this progressive disease, which is caused by the inability of the heart to pump blood to various organs of the body. The heart muscle becomes weak and works harder to keep blood flowing to the rest of the body.
The new device is for patients diagnosed with New York Heart Association Class III and ambulatory Class IV heart failure. These patients are very limited in daily activities. They are comfortable at rest, but unable to do daily activities without becoming tired, short of breath or having heart palpitations.
The C-Pulse® Heart Assist System, developed by Sunshine Heart Inc., (Nasdaq:SSH), is designed to delay the progression of moderate to severe heart failure in patients. Early results have suggested an improvement in overall patient quality of life.
“This is an important trial to help develop a device that can help symptomatic heart failure patients who are not quite ill enough for heart transplantation,” said heart failure specialist Keyur Shah, M.D., assistant professor in the Division of Cardiology at the VCU Pauley Heart Center within the VCU School of Medicine. “Unlike a left ventricular assist device, or LVAD, this technology is not in the bloodstream and may have a reduced risk for stroke, bleeding and bloodstream infections.”
Shah and Daniel Tang, M.D., assistant professor in the Division of Cardiothoracic Surgery at the VCU Pauley Heart Center, are leading the clinical study at VCU.
C-Pulse is a device implanted through a minimally invasive approach to help the heart pump blood. An incision is made in the chest and a cuff is wrapped around the aorta. It inflates and deflates in time with the heart’s pumping motion using information from a sensing lead that monitors the heart’s rhythm. When the cuff inflates, it produces a surge of blood that flows to the heart muscle. No incisions are made into the heart and a heart-lung bypass machine is not required.
The device is designed to reduce the workload of the heart, providing more oxygen-rich blood going to the heart and improving overall heart function. The system works to assist the heart and not replace the heart function, therefore the driver can be safely disconnected for short periods of time, allowing patients to shower, take a walk and perform other activities independent from the system.
To learn more about the COUNTER HF Clinical Study, please call 1-888-978-8391 or visit www.HFClinicalstudy.com.
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