Caution: Investigational device. Limited by United States law to investigational use.
Medtronic is sponsoring a clinical trial that will involve more than 500 patients at up to 90 hospitals in the United States. The purpose of this study is to provide additional information about a medical device intended to help treat high blood pressure in people whose blood pressure is not controlled despite treatment with multiple blood pressure medications.
The study is "Controlled", meaning some of the patients will be treated with the device (the "Treatment Group") and some will NOT be treated with the device (the "Control Group"), and the results of the two groups will be compared.
This study is "Randomized" meaning that patients who are confirmed to be eligible will be randomly assigned to one of two groups. Each patient has a 2 to 1 chance of being assigned to the treatment group. This means you are twice as likely to be in the treatment group rather than the control group. At 6 months, those who were in the control group and remain eligible may be able to have the treatment if they wish.
This study is also "Blinded" meaning that patients will not be told which group they are assigned to, and certain procedures will be followed to prevent patients from knowing which group they are in. This study design is necessary to properly evaluate the safety and effectiveness of the investigational device and procedure.
If you decide to participate in this study, the potential risks and benefits will be thoroughly explained, and you will have the opportunity to discuss participation both with research staff and your family. If selected, your current blood pressure medications (total daily doses and medication types) will not be changed unless medically necessary. In addition to your current blood pressure medications, you may receive treatment with this investigational therapy.
Talk with your doctor about potential risks associated with renal denervation.