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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

Authors
 Chan Joon Kim  ;  Kiyuk Chang  ;  Byeong Keuk Kim  ;  Chang Gyu Park  ;  Yangsoo Jang 
Citation
 KOREAN CIRCULATION JOURNAL, Vol.51(1) : 43-55, 2021-01 
Journal Title
KOREAN CIRCULATION JOURNAL
ISSN
 1738-5520 
Issue Date
2021-01
Keywords
Catheter ablation ; Denervation ; Drug resistance ; Hypertension
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, 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.

Trial registration: ClinicalTrials.gov Identifier: NCT04248530.
Files in This Item:
T202125990.pdf Download
DOI
10.4070/kcj.2020.0391
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Byeong Keuk(김병극) ORCID logo https://orcid.org/0000-0003-2493-066X
Jang, Yang Soo(장양수) ORCID logo https://orcid.org/0000-0002-2169-3112
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/190342
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