A prospective multicenter randomized sham-controlled clinical trial to evaluate the safety and effectiveness of netrodtm radiofrequency renal denervation system for hypertension

Objective: To evaluate the safety and effectiveness of a novel basket-like six-electrode radiofrequency renal denervation (RDN) system (NetrodTM RDN System) in treating patients with uncontrolled hypertension. Design and method: This is a prospective, multicenter, randomized sham-controlled trial. Patients with uncontrolled hypertension (office BP > = 150/90 and <180/110mmHg, and average SBP > = 135mmHg by 24-hour ambulatory BP monitoring (ABPM), after taking > = 2 antihypertensive drugs with stable dose for > = 4 weeks) were screened after informed consent. All eligible patients first entered a lead-in period for > = 4 weeks of standardized medication (Nifedipine + hydrochlorothiazide), and those continued to meet definition of uncontrolled hypertension were randomized 2:1 to RDN group (using NetrodTM RDN System) and sham control group (renal artery angiography only). All continued with the 2-drug regimen and were evaluated at 7 days or discharge (whichever comes first), 1, 2, 3 and 6 months post procedure. Both patients and site investigators who evaluate the patients were blinded to treatment assignment. The primary endpoint is office SBP change from baseline at 6 months post procedure. Secondary endpoints include changes from baseline of office DBP. 24-hour ABPM at 6 months post procedure and safety events. Results: A total of 205 patients from 25 centers were enrolled and 139 randomized to RDN group and 66 to sham control group, with no statistical difference of baseline clinical characteristics between the 2 groups including baseline BP. Compared to baseline, at 6 months post procedure RDN group has a significantly greater office SBP reduction than sham group (25.53 ± 12.62mmHg vs 8.39 ± 11.89mmHg, p < 0.001). Office DBP change was -13.49 ± 8.09mmHg (RDN) vs -3.93 ± 9.04mmHg (sham), p < 0.001. For 24-hour ABPM, the average SBP and DBP reduction were also significantly greater in the RDN vs sham group (11.91 ± 12.23 vs 3.87 ± 12.45mmHg, p < 0.001; 6.03 ± 7.50 vs 1.68 ± 7.30mmHg, p < 0.001, respectively). Device or procedure related serious adverse events were rare throughout the trial. Conclusions: The novel NetrodTM RDN System is safe and effective in treating uncontrolled hypertension with significant reduction in both office and 24-hour ambulatory BP.