Hypertension (high blood pressure) is a major and growing public health concern. An estimated 30-40 out of every 100 adults in the developed world suffers from hypertension. Despite the availability of many safe and helpful therapies, the number of people that have adequate blood pressure control remains low. This leaves people with uncontrolled hypertension at an increased cardiovascular (heart and blood vessel) risk. Thus, the development of new approaches for the management of hypertension is a priority.
The kidneys are an important regulator of blood pressure. Earlier research has shown that disrupting the nerves of the kidney may successfully decrease blood pressure. In the past, one technique that was used to treat severe high blood pressure was a surgical procedure to cut these nerves. However, this surgery is no longer commonly performed. Another less invasive approach to disrupting these nerves is to apply a brief high temperature near the nerves (renal [kidney] denervation). This disrupts the nerve activity to and from the kidneys. This is done using an experimental medical device called the Symplicity® Catheter System™. The System includes a catheter (thin tube) that is inserted into your blood vessels and an energy generator that produces the high temperature. The Symplicity Catheter System is considered an investigational device. Investigational means that the System is not approved by the U.S. Food and Drug Administration (FDA). In earlier research studies, the Symplicity Catheter was used in more than 219 subjects in the US, Europe, and Australia. Those studies have shown that renal denervation can safely and significantly reduce blood pressure in subjects with uncontrolled blood pressure.
The purpose of this study is to provide additional information about the Symplicity Catheter System. We would like to find out if the System can help lower blood pressure in subjects whose blood pressure is not controlled, despite treatment with many blood pressure medications. We also want to find out if the Symplicity Catheter System is safe without causing too many side effects.
You may be eligible to participate in this research study if you:
- Are between 18 and 80 years old
- Have high blood pressure
- Currently receive treatment for high blood pressure with multiple medications
If you or someone you know may be interested in participating, click here.
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