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

Safety and Efficacy of the CE-Marked NetrodTM Renal Denervation System in Treating Patients With Primary Hypertension in the Absence of Anti-hypertensive Medication: a Pilot Study With 20 Subjects

This single-arm, non-randomized, open-label investigation aims 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 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:

1. Subject with age ≥18 years or minimum age as required by local regulations and ≤ 70 years old at time of consent
2. 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.
3. Willing and able to provide informed consent
4. Willing and able to comply with all study-specific visits, assessments, and requirements

Exclusion Criteria:

1. 1. Subject who is pregnant, nursing or planning to become pregnant during the course of the study
2. 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)
3. Subject with single-kidney or history of kidney transplant
4. Subject with history of renal artery intervention (Percutaneous Transluminal Angioplasty [PTA] or stenting) or Renal Denervation (RDN)
5. 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
6. Subject with known secondary hypertension
7. Subject with eGFR <40 mL/min/l.73m²
8. Subject with history of hospitalization for hypertensive emergency within past year
9. Subject with type I diabetes mellitus
10. Subject with primary pulmonary hypertension
11. Subject with history of bleeding diathesis and haematological disorders or coagulopathy
12. Subject with recent history of any embolism within 6 months
13. Subject with history of coronary artery intervention, unstable angina or myocardial infarction
14. Subject with stable angina and therefore treated anti-anginal medication (betablockers, calcium antagonists, long-acting nitrates)
15. Subject with history of abdominal aortic aneurysm
16. Subject with atrial fibrillation or history of atrial fibrillation in the last 3 years or on rate or rhythm control medication for arrhythmia
17. Subject with a history of ventricular fibrillation or ventricular tachycardia
18. Subject known with serum Human Immunodeficiency Virus (HIV)-positive
19. Subject who is allergic to contrast agents and not responding to preventive medication
20. Subject with acute or severe systemic infections
21. Subject with mental illness or any psychological problems that may interfere with participating in the study
22. Subject with history of stroke or transient ischemic attack (TIA)
23. Subject with malignant tumors or end-stage disease
24. Subject with severe Peripheral Artery Disease (PAD) along the access path to renal arteries, including abdominal aneurysm
25. Subject with severe heart valve stenosis or regurgitation
26. Subject with heart failure requiring medications (i.e. Angiotensin-Converting Enzyme (ACE)/ Angiotensin II Receptor Blockers (ARB), Sodium-Glucose Cotransporter 2 Inhibitors (SGTL2i), diuretics)
27. Subject with uncontrolled hyperthyroidism or hypothyroidism
28. 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)
29. Subject who requires mechanical ventilation other than Continuous Positive Airway Pressure (CPAP) for sleep apnea
30. Subject with an implanted pacemaker or Implantable Cardioverter Defibrillator (ICD)/ Cardiac Resynchronization Therapy (CRT) device
31. Subject with a history of major surgery or trauma within 30 days prior to enrolment
32. Subject who has planned surgery or cardiovascular intervention within the next 12 months
33. Subject who is participating in other drug or medical device clinical investigations
34. Subject who is unsuitable to participate in this study in the opinion of investigators (e.g., drug use or alcohol dependency, cognitive impairment, etc.)