The trial, which is called SYMPLICITY HTN-4, is entering its fourth stage of investigation and is only available for investigational purposes in the U.S. The clinical evaluation program of the system, however, includes more than 5,900 patients worldwide. At this time, Piedmont Heart is a leading site in the world for enrollment in current investigations with this technology.
“High blood pressure is a substantial contributing factor for so many conditions, including stroke, heart failure, diabetes, kidney disease and more,” said Kandzari. “For patients who are resistant to high blood pressure medication, the trial offers hope to lower blood pressure and the risk of its adverse consequences.”
The SYMPLICITY trial uses a renal denervation device to disrupt the hyperactive nerves surrounding the artery to each kidney that causes increased blood pressure. A tube is inserted in the groin area and the device is placed into the arteries leading to the kidney. Using radio-frequency energy, multiple treatments are performed in each artery to interrupt the renal nerves’ hyperactivity. The device is removed once the trial procedure is complete.
“One of the body’s primary methods for controlling blood pressure involves the sympathetic nervous system, which includes the brain, heart, kidney and blood vessels,” said Kandzari. “A key factor in long-term blood pressure regulation is the kidney. Renal nerves, which surround the kidney, communicate information from the kidney to the brain and vice versa. For people with hypertension, the renal nerves are excessively active, which raises blood pressure and contributes to heart, kidney and blood vessel damage.”
It is estimated that one in three adults in America — about 68 million people — suffer from high blood pressure, according to the DeKalb County-based Centers for Disease Control and Prevention. This chronic condition poses a serious health threat to nearly six million Americans and 100 million people worldwide.
Information: (404) 605-4098 or visit www.piedmontheart.org.