EuroNetrod HTN OFF-Med Study of Renal Denervation with NetrodTM Six-electrode Radiofrequency RDN System

Launched by SHANGHAI GOLDEN LEAF MEDTEC CO. LTD · Dec 3, 2024

Keywords

ClinConnect Summary

The EuroNetrod HTN OFF-Med Study is a clinical trial that is looking at a new treatment for people with uncontrolled high blood pressure (hypertension) who are not taking any blood pressure medications. The study will compare the effects of a procedure called renal denervation, which uses a special device (the Netrod™ RDN system), to a sham procedure (which is a pretend treatment) and an open-label control group (where participants know they are receiving treatment). The goal is to see how well this new treatment works and if it is safe for patients.

To be eligible for this study, participants need to be between 18 and 80 years old and have high blood pressure readings of 150/90 mmHg or higher. They must also agree to stop taking any current blood pressure medications during the trial. However, certain health conditions may prevent someone from participating, such as having kidney issues, certain heart conditions, or a history of severe high blood pressure emergencies. If someone chooses to participate, they can expect to undergo the renal denervation procedure and have their blood pressure monitored closely over the following months. This trial is not yet recruiting participants, but it aims to help improve treatment options for people with difficult-to-control high blood pressure.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subject with age ≥18 years or minimum age as required by local regulations and ≤80 years old at time of consent
• • 2. 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
• • 3. Subject or his/her legal representative must sign an IEC/REB-approved ICF for the study
• • 4. Subject is willing to discontinue current antihypertensive medications at Screening V1 through the 3-month follow-up visit
• Exclusion Criteria:
• • 1. 1. Subject who is pregnant, nursing or planning to become pregnant during the course of the study
• • 2. 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)
• • 3. Subject with single-kidney or history of kidney transplant
• • 4. Subject with history of renal artery intervention (PTA or stenting) or RDN
• • 5. 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.
• • 6. Subject with known secondary hypertension
• • 7. Subject with eGFR \<40 mL/min/l.73m²
• • 8. Subject with history of hospitalization for hypertensive emergency within past year
• • 9. Subject with type I diabetes mellitus
• • 10. Subject with primary pulmonary hypertension
• • 11. Subject with history of bleeding diathesis and haematological disorders or coagulopathy
• • 12. Subject with recent history of any embolism within 6 months
• • 13. Subject with history of coronary artery intervention, unstable angina or myocardial infarction
• • 14. Subject with stable angina and therefore treated anti-anginal medication (betablockers, calcium antagonists, long-acting nitrates)
• • 15. Subject with history of abdominal aortic aneurysm
• • 16. Subject with atrial fibrillation or history of atrial fibrillation in the last 3 years or on rhythm control medication for arrhythmia
• • 17. Subject with a history of ventricular fibrillation or ventricular tachycardia
• • 18. Subject known with serum HIV-positive
• • 19. Subject who is allergic to contrast agents and not responding to preventive medication
• • 20. Subject with acute or severe systemic infections
• • 21. Subject with mental illness or any psychological problems that may interfere with participating in the study
• • 22. Subject with history of stroke or transient ischemic attack (TIA)
• • 23. Subject with malignant tumors or end-stage disease
• • 24. Subject with severe PAD along the access path to renal arteries, including abdominal aneurysm
• • 25. Subject with severe heart valve stenosis or regurgitation
• • 26. Subject with heart failure requiring medications (i.e. ACE/ARB, SGTL2i, diuretics).
• • 27. Subject with uncontrolled hyperthyroidism or hypothyroidism
• • 28. Subject with severe electrolyte abnormalities, defined as values above and below the limits of normal (ULN) on repeated measurements despite normalization efforts, or with liver function abnormalities, defined as 2 \> ULN
• • 29. Subject who requires mechanical ventilation other than CPAP for sleep apnea
• • 30. Subject with a implanted pacemaker or ICD/CRT device
• • 31. Subject with a history of major surgery or trauma within 30 days prior to enrolment
• • 32. Subject who has planned surgery or cardiovascular intervention within the next 12 months
• • 33. Subject who is participating in other drug or medical device clinical investigations
• • 34. Subject who has known drug or alcohol dependence, difficulty to understand the clinical investigation protocol, inability/unwillingness to follow the clinical investigation protocol
• • 35. Subject who is unsuitable to participate in this study in the opinion of investigators
• • 36. Subjects who are incapacitated or unable to provide informed consent due to cognitive impairment, mental illness, or other conditions that affect their decision-making capacity.