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

Chan Joon Kim, Kiyuk Chang, Byeong Keuk Kim, Chang Gyu Park, Yangsoo Jang

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2 Citations (Scopus)

Abstract

Introduction: 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 2020, 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, 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™ system showed a favorable safety profile in resistant hypertension. A significant reduction in office SBP and a borderline reduction in ambulatory SBP were observed.

Original languageEnglish
Article numbere1
JournalKorean Circulation Journal
Volume51
DOIs
Publication statusPublished - 2020

Bibliographical note

Funding Information:
This research was supported by a grant from the Korea Health Technology R&D Project through the Korea Health Industry Development Institute, funded by the Ministry of Health & Welfare, Republic of Korea (grant No. HI16C0924, HI20C1566), and was funded by Handok Kalos Medical, Seoul, Korea.

Publisher Copyright:
Copyright © 2021.

All Science Journal Classification (ASJC) codes

  • Internal Medicine
  • Cardiology and Cardiovascular Medicine

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