SPYAL HTN-ON Med for Hypertension
You are being asked to take part in a clinical research study because your blood pressure (BP) is not adequately controlled with medications. Purpose of this study is to provide more information about a medical device intended to help treat high blood pressure in patients whose blood pressure is not controlled, despite treatment with up to three blood pressure medications. The kidneys play an important role· in blood pressure control and it is believed that certain nerves in the kidney are overactive in patients with hypertension and contribute to high blood pressure. Medications alone may not be enough to control your blood pressure. Previous research has shown that disrupting the kidney nerves may decrease blood pressure.
If you agree to participate in this research study, you are agreeing to undergo the screening tests, possibly have the renal denervation procedure, and return for follow-up visits for up to 3 to five years, as described in this consent. If you are initially given the renal denervation procedure, you will be followed for 36-months. If you are initially randomized to the control arm, details below, you may have the option to have it approximately 6 months after the initial procedure. After the crossover procedure, you will be followed for 36-months from that time. (Some subjects may be offered the crossover procedure as late as 36-months into the follow up time period). For those subjects, they will need to be followed for an additional 36-months if the crossover procedure occurs, which results in six years of follow up.)
Renal Denervation Catheter ("Spyral catheter") and the Symplicity G3™ Renal Denervation Radiofrequency Generator ("generator") will be used. The generator allows the Spyral™ catheter, which is inserted into your blood vessels, to deliver low-level radiofrequency (RF) "energy" through the wall of a blood vessel to the kidney (renal artery). This will disrupt nerve activity that provides signals to the kidneys and may lower blood pressure.
- Study Identifier: 822545