EuroNetrod HTN OFF-Med Study of Renal Denervation With NetrodTM Six-electrode Radiofrequency RDN … (NCT06722651) | Clinical Trial Compass
WithdrawnNot Applicable
EuroNetrod HTN OFF-Med Study of Renal Denervation With NetrodTM Six-electrode Radiofrequency RDN System
Stopped: This decision aims to concentrate resources on accelerating the development of the next generation of the NetrodTM RDN System.This reflects a broader strategy to advancing more effective solutions for physicians and patients.
Switzerland0Started 2025-08-30
Plain-language summary
This randomized controlled investigation aims to evaluate the efficacy and safety of the Netrodâ„¢ 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Subject with age ≥18 years or minimum age as required by local regulations and ≤80 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 V3 and mean daytime ASBP ≥140 mmHg and \<170 mmHg by 24-hour ABPM at Screening V3
✓. Subject or his/her legal representative must sign an IEC/REB-approved ICF for the study
✓. Subject is willing to discontinue current antihypertensive medications at Screening V1 through the 3-month follow-up visit
Exclusion criteria
✕. 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 (PTA or stenting) or RDN
✕. 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.
✕. Subject with known secondary hypertension
✕
What they're measuring
1
Mean daytime ambulatory systolic blood pressure
Timeframe: From baseline at Screening Visit 2 to Month 3 post-procedure