Iberis-HTN is a prospective, multicenter, blinded, randomized controlled trial to evaluate the safety and efficacy of the Iberis® Multi-Electrode Renal Artery Radiofrequency Ablation Catheter System for the treatment of primary hypertension (NCT02901704).

The study was led by Academician Runlin GAO and Professor Xiongjing JIANG from Fuwai Hospital. 217 subjects were enrolled in the trial. The results showed that the RDN group achieved the primary clinical endpoint of efficacy (change in mean systolic blood pressure from baseline during 24-hour ambulatory blood pressure at 6 months after the procedures) and was significantly superior to the sham control group.

The 24-hour systolic ABPM for Renal denervation (RDN) group was reduced by 11.93 mmHg compared to baseline and the sham group was reduced by 2.58 mmHg. The net change between groups is 9.35 mmHg reduction with statistical significance (P<0.0001). No device related major adverse events were observed. The safety and efficacy of Iberis® were demonstrated in the study.