EuroNetrod HTN OFF-Med Study of Renal Denervation With NetrodTM Six-electrode Radiofrequency RDN System

Shanghai Golden Leaf MedTec Co. Ltd

Overview

This randomized controlled investigation aims to evaluate the efficacy and safety of the Netrod™ RDN system in patients with uncontrolled primary hypertension in the absence of antihypertensive medication, comparing the outcomes between renal denervation, sham procedure, and open-label control groups.

This is a prospective, multi-center, blinded, three-arm randomized controlled study to demonstrate the effectiveness and safety of the Netrod™ RDN system for treating treating patients with uncontrolled primary hypertension in the absence of antihypertensive medications. This clinical investigation will enroll 260 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 three weeks, and those who continue to meet the eligibility requirements will be randomized in a 2:1:1 ratio to one of three groups: renal denervation (RDN), a sham procedure (renal artery angiogram only), or an open-label group (not undergoing the renal angiogram). All subjects randomized to either the treatment or sham procedure groups will be evaluated at hospital discharge. All subjects will be evaluated at 1 and 3 months post-procedure. Additionally, patients who undergo the RDN procedure will also be evaluated at 12, 24, and 36 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. Patients in the RDN and sham-control groups, as well as all clinical follow-up assessors, will be blinded to the treatment allocation. 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 periprocedural major adverse event (MAE) rate at 30 days post-procedure. Subjects enrolled in the sham and open-label control groups may cross over to RDN at three months. Those who cross over will restart the follow-up schedule post-RDN procedure.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Uncontrolled Hypertension

Interventions

Netrod™ six-electrode radiofrequency renal denervation systemDEVICE

Netrod™ renal denervation (RDN) system, which is indicated for the treatment of uncontrolled hypertension. It consists of the following two components: * Netrod™ Six-Electrode Basket Radiofrequency Renal Denervation Catheter and * Netrod™ Renal Denervation Radiofrequency Generator The catheter's electrodes deploy into a self-adaptive basket structure, optimizing contact with the vessel wall for effective ablation.

Sham ProcedureDEVICE

Patients will be remained on the catheterization table for at least 20 min prior to sheath removal.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subject with age ≥18 years or minimum age as required by local regulations and ≤80 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 V3 and mean daytime ASBP ≥140 mmHg and \<170 mmHg by 24-hour ABPM at Screening V3 3. Subject or his/her legal representative must sign an IEC/REB-approved ICF for the study 4. Subject is willing to discontinue current antihypertensive medications at Screening V1 through the 3-month follow-up visit 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 (PTA or stenting) or RDN 5. Subject with any conditions that may affect the accuracy of blood pressure 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 rhythm control medication for arrhythmia 17. Subject with a history of ventricular fibrillation or ventricular tachycardia 18. Subject known with serum 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 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. ACE/ARB, 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 (ULN) on repeated measurements despite normalization efforts, or with liver function abnormalities, defined as 2 \> ULN 29. Subject who requires mechanical ventilation other than CPAP for sleep apnea 30. Subject with a implanted pacemaker or ICD/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 has known drug or alcohol dependence, difficulty to understand the clinical investigation protocol, inability/unwillingness to follow the clinical investigation protocol 35. Subject who is unsuitable to participate in this study in the opinion of investigators 36. Subjects who are incapacitated or unable to provide informed consent due to cognitive impairment, mental illness, or other conditions that affect their decision-making capacity.

Locations (1)

University Hospital Basel

Basel, Canton of Basel-City, Switzerland

Outcomes

Primary Outcomes

Mean daytime ambulatory systolic blood pressure

Between-group difference in baseline adjusted change in mean daytime ambulatory systolic blood pressure (ASBP) at 3 months compared to baseline measured by 24 hours ambulatory blood pressure monitoring (ABPM) (RDN vs sham vs open-label).

Time frame: From baseline at Screening Visit 2 to Month 3 post-procedure

Periprocedural major adverse event (MAE) rate

Periprocedural major adverse event (MAE) rate, defined as a composite of the following events at 30 days post procedure: * All-cause mortality * End-stage renal disease (ESRD) defined as stage 5 CKD (eGFR \< 15 mL/min/l.73m²) or hemodialysis * Significant embolic event resulting in end-organ damage * Renal artery perforation or dissection requiring intervention * Major vascular complications requiring medical or surgical intervention * Hospitalization for hypertensive crisis (unless clearly demonstrated to be associated with non-adherence with antihypertensive medications in the subjects on escape medication) * New renal artery stenosis \> 70% (must be confirmed by angiography)

Time frame: At 30 days post-procedure

Secondary Outcomes

Office blood pressure (BP) and home BP

Changes from baseline in office blood pressure (BP) and home BP at 1- and 3-month post procedure for all enrolled subjects, and 12-, 24- and 36-month post procedure for the subjects who underwent RDN

Time frame: From baseline at Screening Visit 2 to Month 1, 3, 12, 24 and 36 post-procedure

Mean ambulatory BP including 24-hour ASBP and ADBP, daytime and nighttime SBP and DBP

Changes from baseline in mean ambulatory BP including 24-hour ASBP and ADBP, daytime and nighttime SBP and DBP measured by 24-hour ABPM at 1-, 3-month for all enrolled subjects, and 12-, 24- and 36-month for the subjects who underwent RDN.

Time frame: From baseline at Screening Visit 2 to Month 1, 3, 12, 24 and 36 post-procedure

Data from ClinicalTrials.gov

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