A Prospective, Multicenter, Single Arm, Open-label, Early Feasibility Study to Evaluate Initial Safety and Device Design Concept of HyperQureTM RDN System, Laparoscopic Renal Denervation Therapy, in Patients With Resistant Hypertension on Three(3) or More Antihypertensive Medications
HQ-HTN-G01 is a prospective, multicenter, single arm, open label, early feasibility study to evaluate initial safety and device design concept of HyperQureTM RDN System, laparoscopic renal denervation therapy, in patients with resistant hypertension on three(3) or more antihypertensive medications
⁃ Subjects are eligible to participate if all of the following criteria are met:
• Aged ≥22 and ≤80 years old at time of enrollment (consent).
• Diagnosed with resistant hypertension.
• Office BP ≥140/90 mmHg at Screening Visit 1, and on at least 3 antihypertensive medications of different classes including a diuretic for at least 4 weeks prior to consent.
• Daytime ABP ≥135/85 mmHg after a four (4)-week run-in period at Screening Visit 2.
• Agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study.