About this trial
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
Eligibility criteria
Qualifiers
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.
Disqualifiers
Has coverage diameter of renal artery less than 2 mm or greater than 11 mm.
Unstable angina with stent implantation (percutaneous coronary intervention) within 3 months of enrolment.
Myocardial infarction within 3 months of enrollment.
Acute heart failure (New York Heart Association (NYHA) III-IV) within 3 months of enrollment
Trial design
Treatments tested in this trial
- HyperQureTM Renal Denervation (RDN) System: