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

Abstract

Background/objectivesCatheter-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 EnligHTN™ renal denervation system. Six-month primary endpoint data are presented here. MethodsWe conducted this first-in-human, prospective, multi-center, non-randomized study in 39 patients (62% male, mean age 63years, and mean baseline office blood pressure 174/93mmHg) with drug-resistant hypertension. The primary safety and efficacy objectives were to characterize, from baseline to 6months 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. ResultsRenal artery denervation, using the next generation EnligHTN multi-electrode system significantly reduced office blood pressure from baseline to 1, 3, and 6months by −19/7, −26/9 and −25/7mmHg, respectively (P≤0.0005). No serious device or procedure related adverse events affecting the renal arteries or renal function occurred through. ConclusionsRenal 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 6months. Future studies will need to address the utility of this system against an appropriate placebo based comparator.