High blood pressure is one of the most common diseases in the world. Left untreated, it may get worse over time and can lead to serious health complications, such as heart disease or stroke.1 Despite this, many people struggle to control their high blood pressure through lifestyle and medication changes.
If you are trying to control your blood pressure with medications, you know how difficult this can be. Daily medications can initially work well, but often become less effective over time. As the disease progresses, many people need increasing amounts and combinations of medications that can have side effects.
Right now, doctors at select centers in New Zealand are conducting a new research study that may be able to help. The study is evaluating a one-time, minimally-invasive procedure intended to reduce blood pressure without new medications. If you have high blood pressure, we invite you to see if the DeLIVER NZ Study may be right for you.
The purpose of this research study is to evaluate the safety of renal and common hepatic artery denervation in a single procedure using the study device. The study will also monitor for any improvement in blood pressure and other cardiometabolic parameters such as blood sugar changes after the procedure.
High Blood Pressure - The Role of Overactive Nerves
The nerves surrounding the renal arteries (which supply blood to the kidneys) are important in regulating blood pressure. Previous research has shown that disrupting the nerves surrounding the renal arteries can reduce blood pressure. In an earlier study, the Sponsor of this study has shown that disruption of the nerves around the common hepatic artery may also result in an improvement in blood pressure. Additionally, the nerves around the common hepatic artery help to regulate blood sugar levels. Previous research has shown that disrupting the nerves in the hepatic artery (which supplies blood to the liver) may reduce the amount of blood sugar produced from the liver.
The iRF Denervation System
The iRF Denervation System is a catheter based investigational device designed to permanently disrupt overactive nerves through a one-time, minimally invasive procedure.
The iRF procedure is performed through a small incision in the groin. The iRF catheter is guided to the renal artery leading to each kidney and the common hepatic artery leading to the liver. Radiofrequency (heat) energy is delivered from the catheter to the nerves surrounding the arteries. This disrupts the overactive nerves leading to the kidneys and liver. After the procedure is complete, the catheter is removed, leaving nothing behind.
The iRF System is currently being offered through a new clinical research study, called the DeLIVER NZ Study. If you qualify and choose to join the study, you will receive the iRF procedure and all study-related care at no cost to you. Participation in the study will require an overnight stay in the hospital and 4 follow-up visits that may take up to 1 hour per visit.
Why Participate?
If you have high blood pressure you may qualify for the DeLIVER NZ Study. The study is evaluating the iRF Denervation System, an investigational device designed to reduce blood pressure without new medications. If you qualify and choose to join the study, you will receive:
See If You Qualify
The DeLIVER NZ Study is enrolling people ages 22 - 70 who have high blood pressure. To see if you might qualify, and to get connected with your local study centre to learn more, please complete the questionnaire below.