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

Ki vehet részt

• 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

Ki nem vehet részt

• Subject with a history of major surgery or trauma within 30 days prior to enrolment
• Subject who has planned surgery or cardiovascular intervention within the next 12 months
• Subject who is participating in other drug or medical device clinical investigations
• Subject who has known drug or alcohol dependence, difficulty to understand the clinical investigation protocol, inability/unwillingness to follow the clinical investigation protocol
• 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
• Subject with history of hospitalization for hypertensive emergency within past year
• Subject with type I diabetes mellitus
• Subject with primary pulmonary hypertension
• Subject with history of bleeding diathesis and haematological disorders or coagulopathy
• Subject with recent history of any embolism within 6 months
• Subject with history of coronary artery intervention, unstable angina or myocardial infarction
• Subject with history of abdominal aortic aneurysm
• Subject with atrial fibrillation or history of atrial fibrillation in the last 3 years or on rhythm control medication for arrhythmia
• Subject with a history of ventricular fibrillation or ventricular tachycardia
• Subject who is allergic to contrast agents and not responding to preventive medication
• Subject with acute or severe systemic infections
• Subject with mental illness or any psychological problems that may interfere with participating in the study
• Subject with history of stroke or transient ischemic attack (TIA)
• Subject with malignant tumors or end-stage disease
• Subject with severe heart valve stenosis or regurgitation
• Subject with heart failure requiring medications (i.e. ACE/ARB, SGTL2i, diuretics)
• 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
• Subject with eGFR <40 mL/min/l.73m²
• Subject with stable angina and therefore treated anti-anginal medication (betablockers, calcium antagonists, long-acting nitrates)
• Subject known with serum HIV-positive
• 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
• 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 severe PAD along the access path to renal arteries, including abdominal aneurysm
• Subject with uncontrolled hyperthyroidism or hypothyroidism
• Subject who requires mechanical ventilation other than CPAP for sleep apnea
• Subject with a implanted pacemaker or ICD/CRT device
• Subject who is unsuitable to participate in this study in the opinion of investigators