Netrod-Pilot Study of Renal Denervation With NetrodTM Sixelectrode Radiofrequency RDN System (NCT07061054) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Netrod-Pilot Study of Renal Denervation With NetrodTM Sixelectrode Radiofrequency RDN System
Spain20 participantsStarted 2026-04-01
Plain-language summary
This single-arm, non-randomized, open-label investigation aims to collect safety and efficacy data of the CE-Marked Netrodâ„¢ RDN System in treating European patients with primary hypertension in the absence of anti-hypertensive medication.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. 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
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 (Percutaneous Transluminal Angioplasty \[PTA\] or stenting) or Renal Denervation (RDN)
✕. Subject with any conditions that may affect the accuracy of blood pressure (BP) 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
Incidence of periprocedure major adverse event (MAE)
Timeframe: Through 30 days post index procedure
2
Mean daytime ambulatory systolic blood pressure (ASBP)
Timeframe: From baseline to 3 months post index procedure