EuroNetrod HTN OFF-Med Study is a multi-center blinded, 3-arm randomized (2:1:1) controlled investigation that 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. Despite available treatments, many patients do not achieve guideline recommended blood pressure control.
The Netrod™ RDN system, designed to modulate renal autonomic nervous system activity, may offer an effective non-pharmacological option. This study will provide evidence on its effectiveness and explore the clinical value of different control types in RDN clinical trials by comparing the BP lowering effects of sham-controls to open-label controls.
Sponsor
Shanghai Golden Leaf MedTech Co., Ltd
Study objectives
The objective is to enroll 260 eligible subjects to the RDN vs sham vs open-label control group by a randomization ratio of 2:1:1.
The study duration for each subject is expected to be approximately 37.5 months (about 41 months for the cross-over patients).
The total study duration is estimated at around 5.5 years. All enrolled subjects will be evaluated at hospital discharge, 1- and 3-month post procedure; and those who underwent RDN procedure will also be assessed at 12-, 24- and 36-month post procedure
Primary endpoints
Primary efficacy endpoint:
- 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).
Primary efficacy endpoint:
- Periprocedural major adverse event (MAE) rate at 30 days post procedure
CERC Services
- Clinical report
- Clinical trial documentation
- CoreLab activities
- Monitoring activities
- Project management
- Safety reporting
- Set-up activities (sites selection, insurance management, contract management)
- Submission to competent authorities and ethic committees
Countries
This clinical investigation will be conducted in up to 25 clinical sites located in Europe.
Number of investigational sites
25
