Early Feasibility Study of the HyperQureTM Laparoscopic Renal Denervation System for Patients with Resistant Hypertension on Three or More Blood Pressure Medications

What this Trial Is About

This trial evaluates the safety and design of the HyperQureTM Renal Denervation RDN System, a laparoscopic device intended for patients with resistant hypertension who are taking three or more blood pressure medications including a diuretic. The study aims to demonstrate the concept of complete ablation through extravascular renal denervation and to establish a foundation for further pivotal studies. This approach seeks to overcome limitations found in catheter-based renal denervation by accessing the renal arteries externally. Participants will undergo laparoscopic renal denervation using the HyperQureTM system, which delivers radiofrequency energy around the renal artery through a minimally invasive retroperitoneal approach. The procedure wraps 360 degrees around the renal artery and targets main renal arteries and suitable branch or accessory vessels based on pre-procedure imaging. Treatment parameters include maintaining 50 degrees Celsius for 70 seconds per application. The study includes a single treatment arm and will enroll 15 adults. After the procedure under general anesthesia, participants will be monitored for 36 months with regular evaluations of blood pressure using 24-hour ambulatory, office, and home measurements. Imaging scans such as CTA and ultrasound will assess the renal arteries. The main outcomes measured include changes in 24-hour ambulatory systolic blood pressure at 3 months and the incidence of major adverse events within 1 month. Extended follow-up will track blood pressure changes and safety events up to 36 months.

Early Feasibility Study of "HyperQureTM RDN System", Laparoscopic Renal Denervation Therapy, in Patients With Resistant Hypertension