An Open-label, Single-arm, Multicenter Feasibility Study Evaluating the Safety of Catheter-based Renal Denervation with DENEX (TM) in Patients with Uncontrolled Hypertension on Standard Medical Therapy

Abstract

Background and Objectives: DENEX (TM) is a novel renal sympathetic denervation (RDN) system that is equipped with 3 electrodes that deliver radiofrequency energy to the renal nerves along renal arteries. The purpose of this study was to evaluate the safety and efficacy of RDN with DENEX (TM) in resistant hypertension. Methods: This was an open-label, single-arm, multicenter, first-in-man pilot study. Between November 2016 and May 2018, a total of 16 patients were enrolled at 4 centers in South Korea. The inclusion criteria were systolic blood pressure (SBP) >= 150 mmHg and use of 3 or more antihypertensive medications, including diuretics. The primary objective was the safety outcome of RDN with the DENEX (TM) system. The secondary objective was efficacy outcome based on changes of office, and 24-hour ambulatory SBP from baseline to 3 months. The patients underwent abdominal computed tomography (CT) or duplex ultrasonogram before and 6 months after RDN. Results: No major adverse events occurred after RDN for 6 month of follow-up period. There was no vascular complication either by CT or duplex ultrasonogram. The office SBP was significantly reduced from 164.6 +/- 11.6 mmHg at baseline to 142.0 +/- 20.4 mmHg (-24.4 +/- 24.4 mmHg, p=0.003) at 3 months. The ambulatory SBP was reduced from 151.44 +/- 12.85 mmHg at baseline to 140.0 +/- 16.5 mmHg (-13.1 +/- 18.9 mmHg, p=0.056) at 3 months. Conclusion: RDN with the DENEX (TM) system showed a favorable safety profile in resistant hypertension. A significant reduction in office SBP and a borderline reduction in ambulatory SBP were observed.