Netrod-Pilot Study of Renal Denervation With NetrodTM Sixelectrode Radiofrequency RDN System

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Netrod™ six-electrode radiofrequency renal denervation system
  Netrod™ renal denervation (RDN) system, which is indicated for the treatment of uncontrolled hypertension. It consists of the following two components: Netrod™ Six-Electrode Basket Radiofrequency Renal Denervation Catheter and Netrod™ Renal Denervation Radiofrequency Generator. The catheter's electrodes deploy into a self adaptive basket structure, optimizing contact with the vessel wall for effective ablation.

Первичные конечные точки

• Incidence of periprocedure major adverse event (MAE) [Срок оценки: Through 30 days post index procedure]
• Mean daytime ambulatory systolic blood pressure (ASBP) [Срок оценки: From baseline to 3 months post index procedure]

Вторичные конечные точки (8)

• Incidence of the safety events [Срок оценки: At 3, 6 and 12 months post procedure]
• Incidence of serious adverse events (SAEs) related to the investigational device [Срок оценки: From day 0 (procedure) to 12 months post index procedure]
• Incidence of device deficiency [Срок оценки: At Visit 3, day 0 (procedure)]
• Mean ambulatory BP [Срок оценки: From baseline at Visit 2 to 3- and 12-month post index procedure]
• Office blood pressure (OBP) [Срок оценки: From baseline at Visit 2 to 1-, 3-, 6- and 12-month post index procedure]
• Percentage of patients with office systolic blood pressure within target range [Срок оценки: At 3-, 6- and 12-month post index procedure]
• Percentage of patients with mean ASBP within the target range [Срок оценки: At 3- and 12-month post index procedure]
• Proportion of OSBP decreased by ≥ 5, 10, 15 and 20 mmHg [Срок оценки: At 3-month post index procedure]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Barcelona Clinic Hospital — Barcelona

Публикации

• Li Y, Gao F, Ren C, Ma G, Bu P, Fu G, Chen H, Han Z, Li Y, Li J, Ma X, Hao L, Chen Y, Chen M, Chen X, Liu X, Jiang J, Yu J, Li N, Ma X, Yang B, Cong H, Wang X, Fan Q, Lv S, Wu D, Dai Q, Qiu F, Cai H, Zhou YJ. The Netrod six-electrode radiofrequency renal denervation system for uncontrolled hypertension: a sham-controlled trial. Eur Heart J. 2024 Nov 21;45(44):4761-4764. doi: 10.1093/eurheartj/ehae PMID 39431289

Идентификаторы

NCT: NCT07061054 · Netrod OFF-MED Pilot

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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