Safety and Efficacy of the CE-Marked NetrodTM Renal Denervation System in Treating Patients With Primary Hypertension in the Absence of Anti-hypertensive Medication: a Pilot Study With 20 Subjects
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incidence of periprocedure major adverse event (MAE)
研究概览
简要总结
This single-arm, non-randomized, open-label investigation aims to collect safety and efficacy data of the CE-Marked Netrod™ RDN System in treating European patients with primary hypertension in the absence of anti-hypertensive medication.
详细描述
This is a prospective, single-arm, non-randomized, open-label, multi-center study to collect safety and efficacy data of the CE-Marked Netrod™ RDN System in treating European patients with primary hypertension in the absence of anti-hypertensive medication. This clinical investigation aims to enroll 20 patients in Europe. Patients with uncontrolled primary hypertension (office BP ≥150/90 mmHg and <180/110 mmHg) who are willing to discontinue antihypertensive medications will be screened after providing informed consent.
All eligible patients will undergo a medication washout period of at least 21 days, and those who continue to meet the eligibility requirements will undergo the RDN procedure using the Netrod™ RDN System. Subjects will be evaluated at hospital discharge and at 1, 3, 6, and 12 months post-procedure. All subjects will remain off antihypertensive medications until the primary endpoint is assessed at the 3-month follow-up visit, after which antihypertensive medications may be reintroduced.
The primary efficacy endpoint is the change in daytime ambulatory systolic blood pressure (ASBP) from baseline at three months post-procedure. The primary safety endpoint is the incidence of periprocedural major adverse event (MAE) rate through 30 days post index procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 V
- •Willing and able to provide informed consent
- •Willing and able to comply with all study-specific visits, assessments, and requirements
排除标准
- •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
- •Subject with eGFR <40 mL/min/l.73m²
- •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 stable angina and therefore treated anti-anginal medication (betablockers, calcium antagonists, long-acting nitrates)
- •Subject with history of abdominal aortic aneurysm
- •Subject with atrial fibrillation or history of atrial fibrillation in the last 3 years or on rate or rhythm control medication for arrhythmia
- •Subject with a history of ventricular fibrillation or ventricular tachycardia
- •Subject known with serum Human Immunodeficiency Virus (HIV)-positive
- •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 Peripheral Artery Disease (PAD) along the access path to renal arteries, including abdominal aneurysm
- •Subject with severe heart valve stenosis or regurgitation
- •Subject with heart failure requiring medications (i.e. Angiotensin-Converting Enzyme (ACE)/ Angiotensin II Receptor Blockers (ARB), Sodium-Glucose Cotransporter 2 Inhibitors (SGTL2i), diuretics)
- •Subject with uncontrolled hyperthyroidism or hypothyroidism
- •Subject with severe electrolyte abnormalities, defined as values above and below the limits of normal (LN) on repeated measurements despite normalization efforts, or with liver function abnormalities, defined as 2 > Upper Limit of Normal (ULN)
- •Subject who requires mechanical ventilation other than Continuous Positive Airway Pressure (CPAP) for sleep apnea
- •Subject with an implanted pacemaker or Implantable Cardioverter Defibrillator (ICD)/ Cardiac Resynchronization Therapy (CRT) device
- •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 is unsuitable to participate in this study in the opinion of investigators (e.g., drug use or alcohol dependency, cognitive impairment, etc.)
研究组 & 干预措施
Renal Denervation
Renal angiogram and Renal Denervation procedure
干预措施: Netrod™ six-electrode radiofrequency renal denervation system (Device)
结局指标
主要结局
Incidence of periprocedure major adverse event (MAE)
时间窗: Through 30 days post index procedure
Incidence of periprocedure major adverse event (MAE), defined as a composite of the following events through 30 days post index procedure (except for new renal artery stenosis): * All-cause mortality * End-stage renal disease (ESRD) defined as stage 5 Chronic Kidney Disease (CKD) (Estimated Glomerular Filtration Rate (eGFR) \< 15 mL/min/l.73m²) or hemodialysis * Significant embolic event resulting in end-organ damage * Renal artery perforation or dissection requiring intervention * Major vascular complications requiring medical or surgical intervention * Hospitalization for hypertensive crisis (unless clearly demonstrated to be associated with non-adherence with antihypertensive medications in the subjects on escape medication) * New renal artery stenosis \> 70% (must be confirmed by angiography)
Mean daytime ambulatory systolic blood pressure (ASBP)
时间窗: From baseline to 3 months post index procedure
Changes from baseline in mean daytime ambulatory systolic blood pressure (ASBP) by 24-hour ambulatory blood pressure monitoring (ABPM) at 3 months post index procedure
次要结局
- Incidence of device deficiency(At Visit 3, day 0 (procedure))
- Incidence of the safety events(At 3, 6 and 12 months post procedure)
- Incidence of serious adverse events (SAEs) related to the investigational device(From day 0 (procedure) to 12 months post index procedure)
- Office blood pressure (OBP)(From baseline at Visit 2 to 1-, 3-, 6- and 12-month post index procedure)
- Mean ambulatory BP(From baseline at Visit 2 to 3- and 12-month post index procedure)
- Percentage of patients with office systolic blood pressure within target range(At 3-, 6- and 12-month post index procedure)
- Percentage of patients with mean ASBP within the target range(At 3- and 12-month post index procedure)
- Proportion of OSBP decreased by ≥ 5, 10, 15 and 20 mmHg(At 3-month post index procedure)