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.
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
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)
Single group
Netrod™ six-electrode radiofrequency renal denervation system
DeviceNetrod™ 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.
Incidence of periprocedure major adverse event (MAE)
Incidence of periprocedure major adverse event (MAE), defined as a composite of the following events through 30 days post index procedure (except for new renal artery stenosis): * All-cause mortality * End-stage renal disease (ESRD) defined as stage 5 Chronic Kidney Disease (CKD) (Estimated Glomerular Filtration Rate (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)
Mean daytime ambulatory systolic blood pressure (ASBP)
Changes from baseline in mean daytime ambulatory systolic blood pressure (ASBP) by 24-hour ambulatory blood pressure monitoring (ABPM) at 3 months post index procedure
Incidence of the safety events
Incidence of the following events: * All-cause mortality * ESRD defined as stage 5 CKD (eGFR \< 15 mL/min/l.73m²) * ≥50% decline in eGFR or \>50% increase in serum creatinine from baseline * New myocardial infarction or acute coronary syndrome (ACS) * New stroke or Cerebrovascular Accident (CVA) * Renal artery reintervention * New renal artery stenosis \> 70% confirmed by angiography * Hospitalization for hypertensive crisis not related to confirmed non-adherence of anti-hypertensive medications * Hospitalization for major cardiovascular- or hemodynamic-related events (such as heart failure or atrial fibrillation)
Incidence of serious adverse events (SAEs) related to the investigational device
The incident of serious adverse events (SAEs) related to the investigational device within 12 months post index procedure.
Incidence of device deficiency
Incidence of device deficiency
Mean ambulatory BP
Changes from baseline in mean ambulatory BP including 24-hour ambulatory blood pressure, including ASBP and Ambulatory Diastolic Blood Pressure (ADBP), daytime and nighttime Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) measured by ABPM at 3- and 12-month post index procedure (except 24-hour mean daytime ASBP at 3-month post index procedure, which is already included in the primary endpoint)
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Shanghai Golden Leaf MedTec Co. Ltd
Lead sponsor
North American Science Associates Ltd.
Collaborator
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