Efficacy and safety of extravascular renal denervation in patients with resistant hypertension: a study protocol for a pilot, single-arm, multi-center, first-in-human study.

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 catheter-based 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. Trial registration: Clinical Research Information Service Identifier: KCT0009209.