Netrod-Pilot Study of Renal Denervation With NetrodTM Sixelectrode Radiofrequency RDN System

This is a prospective, single-arm, non-randomized, open-label, multi-center study to collect safety and efficacy data of the CE-Marked Netrod™ RDN System in treating European patients with primary hypertension in the absence of anti-hypertensive medication. This clinical investigation aims to enroll 20 patients in Europe. Patients with uncontrolled primary hypertension (office BP ≥150/90 mmHg and <180/110 mmHg) who are willing to discontinue antihypertensive medications will be screened after providing informed consent.

All eligible patients will undergo a medication washout period of at least 21 days, and those who continue to meet the eligibility requirements will undergo the RDN procedure using the Netrod™ RDN System. Subjects will be evaluated at hospital discharge and at 1, 3, 6, and 12 months post-procedure. All subjects will remain off antihypertensive medications until the primary endpoint is assessed at the 3-month follow-up visit, after which antihypertensive medications may be reintroduced.

The primary efficacy endpoint is the change in daytime ambulatory systolic blood pressure (ASBP) from baseline at three months post-procedure. The primary safety endpoint is the incidence of periprocedural major adverse event (MAE) rate through 30 days post index procedure.

Inclusion criteria

• Subject with age ≥18 years or minimum age as required by local regulations and ≤ 70 years old at time of consent
• Subject with hypertension who has an office BP of ≥ 150/90 mmHg and < 180/110 mmHg (meet both SBP and DBP criteria) at Screening V2, and mean daytime ASBP ≥ 140 mmHg and < 170 mmHg by 24-hour ABPM at Screening V2.
• Willing and able to provide informed consent
• Willing and able to comply with all study-specific visits, assessments, and requirements

Exclusion criteria

• 1. Subject who is pregnant, nursing or planning to become pregnant during the course of the study
• Subject with unilateral or bilateral renal artery that are not suitable for ablation procedure (renal artery stenosis more than 50%, renal aneurysm, renal artery abnormality, renal artery diameter < 3 mm or treatable segment length < 20 mm)
• Subject with single-kidney or history of kidney transplant
• Subject with history of renal artery intervention (Percutaneous Transluminal Angioplasty [PTA] or stenting) or Renal Denervation (RDN)
• Subject with any conditions that may affect the accuracy of blood pressure (BP) measurement: such as the diameter of the upper arm is too large for the cuff, or arrhythmia, etc
• Subject with known secondary hypertension
• Subject with eGFR <40 mL/min/l.73m²
• Subject with history of hospitalization for hypertensive emergency within past year
• Subject with type I diabetes mellitus
• Subject with primary pulmonary hypertension
• Subject with history of bleeding diathesis and haematological disorders or coagulopathy
• Subject with recent history of any embolism within 6 months
• Subject with history of coronary artery intervention, unstable angina or myocardial infarction
• Subject with stable angina and therefore treated anti-anginal medication (betablockers, calcium antagonists, long-acting nitrates)
• Subject with history of abdominal aortic aneurysm
• Subject with atrial fibrillation or history of atrial fibrillation in the last 3 years or on rate or rhythm control medication for arrhythmia
• Subject with a history of ventricular fibrillation or ventricular tachycardia
• Subject known with serum Human Immunodeficiency Virus (HIV)-positive
• Subject who is allergic to contrast agents and not responding to preventive medication
• Subject with acute or severe systemic infections
• Subject with mental illness or any psychological problems that may interfere with participating in the study
• Subject with history of stroke or transient ischemic attack (TIA)
• Subject with malignant tumors or end-stage disease
• Subject with severe Peripheral Artery Disease (PAD) along the access path to renal arteries, including abdominal aneurysm
• Subject with severe heart valve stenosis or regurgitation
• Subject with heart failure requiring medications (i.e. Angiotensin-Converting Enzyme (ACE)/ Angiotensin II Receptor Blockers (ARB), Sodium-Glucose Cotransporter 2 Inhibitors (SGTL2i), diuretics)
• Subject with uncontrolled hyperthyroidism or hypothyroidism
• Subject with severe electrolyte abnormalities, defined as values above and below the limits of normal (LN) on repeated measurements despite normalization efforts, or with liver function abnormalities, defined as 2 > Upper Limit of Normal (ULN)
• Subject who requires mechanical ventilation other than Continuous Positive Airway Pressure (CPAP) for sleep apnea
• Subject with an implanted pacemaker or Implantable Cardioverter Defibrillator (ICD)/ Cardiac Resynchronization Therapy (CRT) device
• Subject with a history of major surgery or trauma within 30 days prior to enrolment
• Subject who has planned surgery or cardiovascular intervention within the next 12 months
• Subject who is participating in other drug or medical device clinical investigations
• Subject who is unsuitable to participate in this study in the opinion of investigators (e.g., drug use or alcohol dependency, cognitive impairment, etc.)