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)
Shanghai Golden Leaf MedTec Co. Ltd
Lead sponsor
North American Science Associates Ltd.
Collaborator