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

Prior treatment

• Has one or more of the following conditions:
  • 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
  • Cerebrovascular accident or transient ischemic attack within 3 months of enrollment.
  • Atrial fibrillation patients undergoing treatment and not in sinus rhythm. Notes: Patients who have received medical treatment, catheter or surgical treatment for atrial fibrillation and are in sinus rhythm are not excluded
• Has one or more of the following confirmed anatomical findings in the kidney or renal artery that are not suitable for renal denervation (assessed by the renal CT angiography of Screening 2)
  • A single functioning kidney.
  • An atheroma, aneurysm or renal artery stent within 5 mm of the renal denervation site.
  • Presence of stenosis of 30% or more on all of the blood vessels available for renal denervation therapy.
  • When it is deemed impossible to perform denervation on both renal arteries according to the discretion of the investigator.
• Has comorbidities or surgical/procedural history that are not suitable for retroperitoneal approach
  • Surgical history through retroperitoneal approach.
  • Fibrosis in the retroperitoneal region.
  • Inflammation in the retroperitoneal region.
  • Severe obesity (body mass index (BMI) \> 40 kg/m2)
  • Risk of increased intracranial pressure
• Has a scheduled or planned surgery that, in the opinion of the Investigator, may affect study endpoints.
• Prescribed any standard antihypertensive cardiovascular medication for other chronic conditions (e.g. ischemic heart disease) for less than 90 days before Screening visit 1 and whose discontinuation might pose serious risk to health.
• Has frequent intermittent or chronic pain that results in the treatment with non-steroidal anti-inflammatory drugs (NSAIDs) for two (2) or more days per week over the month prior to Screening Visit 2.
• Concurrent enrollment in any other investigational drug or device study(Participation in non-interventional Registries is acceptable).

Other illness

• Has one or more of the following medical history or a history of surgery/procedure that is not suitable for renal denervation therapy
  • Renal denervation therapy.
  • Polycystic kidney disease (PKD).
  • Atrophic kidney.
  • Kidney transplant.
  • Dialysis due to end-stage renal disease.
  • Any surgery performed on both kidneys. (except endoscopy type of surgery, i.e. endoscopic kidney stone removal)
  • FMD (Fibromuscular dysplasia)
• Has a history of any intervention for underlying renal artery pathology including stenting or balloon angioplasty.
• Type I diabetes mellitus or uncontrolled Type II diabetes (defined as a plasma Hb1Ac ≥ 9.0%).
• Has documented primary pulmonary hypertension.
• Has an untreated secondary cause of hypertension (either known or suspected) or is taking drugs that increase sympathetic tone and could contribute to hypertension.
• Has severe cardiac valve stenosis for which, in the opinion of the Investigator, a significant reduction of blood pressure is contraindicated.
• Has a known unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable, in the opinion of the Investigator, to comply with study follow-up requirements.
• Has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
• Allergy, intolerance or contraindications to contrast medium.

Lab values

• Individual has an eGFR of \<45 mL/min/1.73m2, using the 4 variable Modification of Diet in Renal Disease (MDRD) calculation (in mL/min) per 1.73 m2 = 175 x Serum Cr-1.154 x age-0.203 x 1.212 (if patient is black) x 0.742 (if female).
• Is pregnant, nursing or planning to become pregnant during the course of the study follow-up (Note: Female participants of childbearing potential must have a negative serum or urine human chorionic gonadotropin (hCG) pregnancy test prior to angiography).

Other

• Subjects are not eligible to participate if any of the following criteria are met:
• Has coverage diameter of renal artery less than 2 mm or greater than 11 mm.
• Has had a reduction of SBP of ≥20 mm Hg or DBP of ≥10 mm Hg within 3 minutes of standing coupled with symptoms during the screening process (at Screening Visit 2).
• Requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea (e.g., CPAP, BiPAP).
• Works night shifts.
• Patients who are at high risk if taken off their anticoagulant and antiplatelet agents for a few days.

• 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.