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

ABSTRACT:

Background and objectives

DENEX™ 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™ 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™ system. The secondary objective was efficacy outcome based on changes of office,

SUBMITTER: Kim CJ 

PROVIDER: S-EPMC7779817 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature