St Joseph Hospital has enrolled first patient for SYMPLICITY HTN-3 trial, conducted by Medtronic, designed to assess investigational Symplicity renal denervation system.
Minimally invasive, catheter-based renal denervation procedure is designed for regulating the output of sympathetic nerves that line the walls of the arteries leading to the kidneys.
The controlled, randomized trial is designed to demonstrate the safety and effectiveness of renal denervation with the Symplicity renal denervation system in patients with treatment-resistant hypertension and systolic blood pressure higher than 160 mmHg.
Two patients enrolled in the SYMPLICITY HTN-3 trial will be considered as treatment group, while one will be assigned as the control group and may receive the treatment after a six-month period passes.
Investigational treatment receiving patients will be compared with a control group patients continuing on blood pressure medications.
The primary endpoints of the study include change in blood pressure from baseline to six months and incidence of major adverse events.
The renal denervation technology has shown to reduce blood pressure by about 30 points in patients with resistant hypertension, according to the company.
St Joseph Hospital interventional radiologist and study principal investigator Mahmood K. Razavi said the anticipated clinical trial address an important public health issue.
"We enrolled our first patient in the clinical trial on Wednesday when we conducted a procedure in our Interventional Radiology suite," Razavi added.