Safety and performance of the next generation EnligHTNTM renal denervation system in patients with drug-resistant, uncontrolled hypertension: The EnligHTN III first-in-human multicentre study.

Abstract

Background/objectives Catheter-based renal denervation for the treatment of drug-resistant hypertension has been intensively investigated in recent years. To date, only limited data have been published using multi-electrode radiofrequency ablation systems that can deliver lesions with a pre-determined pattern. This study was designed to evaluate the safety and efficacy of the next generation EnligHTNTM renal denervation system. Six-month primary endpoint data are presented here. Methods We conducted this first-in-human, prospective, multi-center, non-randomized study in 39 patients (62% male, mean age 63 years, and mean baseline office blood pressure 174/93 mm Hg) with drug-resistant hypertension. The primary safety and efficacy objectives were to characterize, from baseline to 6 months post-procedure, the rate of serious procedural and device related adverse events, as adjudicated by an independent Clinical Events Committee, and the reduction of office systolic blood pressure. Results Renal artery denervation, using the next generation EnligHTN multi-electrode system significantly reduced office blood pressure from baseline to 1, 3, and 6 months by - 19/7, - 26/9 and - 25/7 mm Hg, respectively (P <= 0.0005). No serious device or procedure related adverse events affecting the renal arteries or renal function occurred through. Conclusions Renal sympathetic denervation using the next generation EnligHTN renal denervation system resulted in safe, rapid, and significant mean office blood pressure reduction that was sustained through 6 months. Future studies will need to address the utility of this system against an appropriate placebo based comparator.Copyright © 2015 The Authors.