Extravascular renal denervation using the HyperQure system will be evaluated for safety and preliminary efficacy on 24-hour ambulatory systolic blood pressure in a first-in-human trial of 10 patients with resistant hypertension.
Does extravascular renal denervation using the HyperQure RDN System reduce 24-hour ambulatory systolic blood pressure in patients with resistant hypertension?
This study protocol outlines a first-in-human trial to evaluate the safety and efficacy of a novel extravascular renal denervation system for resistant hypertension.
Background: Although catheter-based renal denervation (RDN) has emerged as a potential treatment for resistant hypertension, it has limitations, including incomplete denervation and anatomical constraints.To address these challenges, we introduce the HyperQure RDN System, a novel extravascular RDN procedure targeting the renal artery adventitia, where renal sympathetic nerves are primarily distributed, for a more complete denervation.Methods: This pilot, single-arm, multicenter, first-in-human trial will evaluate the efficacy and safety of an extravascular RDN system in patients with hypertension.Ten patients aged 19-79 years with uncontrolled hypertension despite using three or more antihypertensive medications will undergo extravascular RDN.The procedure involves a retroperitoneal laparoscopic approach to achieve circumferential ablation of the sympathetic nerves surrounding the renal artery.A repeat procedure can be performed at different locations on the artery or by targeting branch vessels and accessory arteries.The primary efficacy outcome is the change in 24-hour ambulatory systolic blood pressure at 3 months post-procedure.Safety endpoints include the incidence of overall, major, acute/procedural, and chronic adverse events.Conclusions: Extravascular RDN has the potential to overcome the limitations of catheterbased techniques by enabling more complete sympathetic denervation that targets a broader range of renal sympathetic nerve fibers.This trial will generate critical first-in-human data to guide future clinical applications of extravascular RDN.
Yoon et al. (Thu,) conducted a other in Resistant hypertension (n=10). Extravascular renal denervation (HyperQure RDN System) was evaluated on Change in 24-hour ambulatory systolic blood pressure from baseline to 3 months post-procedure. Extravascular renal denervation using the HyperQure system will be evaluated for safety and preliminary efficacy on 24-hour ambulatory systolic blood pressure in a first-in-human trial of 10 patients with resistant hypertension.