Researchers at the Emory Heart & Vascular Center are participating in a global pivotal trial as they continue to evaluate renal denervation, an innovative approach to help lower high blood pressure independent of medication.
Approval for an investigational device exemption (IDE) pivotal trial was recently granted by the FDA, giving Emory the green light to continue efforts that started in 2016 investigating Medtronic’s Symplicity SPYRAL renal denervation system in patients with hypertension.
The study, called the SPYRAL HTN Pivotal Trial, aims to determine the efficacy and safety of renal denervation. The minimally invasive procedure uses radiofrequency (RF) energy to quiet overactive sympathetic nerve signals to the kidneys. These nerves are responsible for regulating the body's water and salt balance, and when they over perform, the body’s ability to control high blood pressure is affected.
"This study will help us fully investigate renal denervation and greatly advance clinical knowledge that may result in a new approach to blood pressure control, potentially impacting countless patients with hypertension,” says Emory Healthcare cardiologist Chandan Devireddy, MD, associate professor of medicine, Emory University School of Medicine.
The SPYRAL HTN Pivotal Trial is a randomized study investigating the renal denervation procedure in up to 433 patients at 50 sites in the United States, Europe, Australia and Japan. The trial will investigate the blood pressure lowering effect and safety of renal denervation in the absence of medication. The primary efficacy and safety endpoints in the trial are 24-hour blood pressure at three months and incidence of major adverse events through one-month post-randomization.
During the procedure, a catheter is advanced through a minimal puncture in a groin artery and then threaded into the kidney arteries. Once there, the catheter delivers low-power RF energy to heat nerves in the walls of the artery with the goal of reducing the impact these nerves play in raising blood pressure. The technique, called ablation, is similar to one commonly used by doctors to stabilize irregular heartbeats.
According to Devireddy, SPYRAL's minimally invasive approach to deactivate these overactive nerves from the inside of the kidney arteries has been made possible by matching technical advances of the 21stcentury with well described physiologic principles. Devireddy is the site principal investigator of the SPYRAL trial at Emory.
For more information on the SPYRAL trial at Emory, please call 404-686-7468. To learn more about the SPYRAL clinical trial program, please visit www.spyralhtntrials.com