NCT01699529已完成不适用
Multi-electrode Radiofrequency Renal Denervation System Feasibility Study
Medtronic Vascular7 个研究点 分布在 2 个国家目标入组 50 人开始时间: 2012年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 7
- 主要终点
- Acute safety as measured by procedural complications
研究概览
简要总结
This is a prospective, single-arm, non-randomized and open label feasibility study. The study is intended to evaluate safety and efficacy of multi-electrode radiofrequency renal denervation in patients with uncontrolled hypertension.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individual is ≥ 18 and ≤ 80 years old.
- •Individual has an office systolic blood pressure of 160 mmHG or greater (≥ 150 mmHg for Type 2 diabetics) based on an average of 3 office/clinic blood pressure readings
- •Individual is adhering to a stable medication regimen including ≥ 3 anti-hypertensive medications(preferred that one is a diuretic) for a minimum of two weeks prior to screening.
排除标准
- •Individual has an estimated glomerular filtration rate (eGFR) of < 45 mL/min/1.73 m2
- •Individual has type 1 diabetes mellitus
- •Individual requires chronic oxygen support or mechanical ventilation (e.g., tracheostomy, CPAP, BiPAP) other than nocturnal respiratory support for sleep apnea.
- •Individual has primary pulmonary hypertension.
- •Individual is pregnant, nursing or planning to be pregnant.
结局指标
主要结局
Acute safety as measured by procedural complications
时间窗: 1 month
次要结局
- Change in Office Systolic Blood Pressure(Baseline to 6 months)
研究者
研究点 (7)
Loading locations...
相似试验
已完成
不适用
Efficacy and Safety of Radiofrequency Renal Denervation in Drug Resistant HypertensionHypertensionNCT01499810Tomsk National Research Medical Center of the Russian Academy of Sciences53
已完成
不适用
Safety and Efficacy Study of Renal Artery Ablation in Resistant Hypertension PatientsHypertensionNCT01438229Abbott Medical Devices47
招募中
不适用
DENEX Renal Denervation in Patients With Hypertension on no Antihypertensive MedicationsVascular DiseasesCardiovascular DiseasesHypertensionNCT04535050Kalos Medical100
已完成
不适用
Evaluation of the Integrated Radio Frequency Denervation System for the Treatment of HypertensionMetabolic SyndromeHypertensionNCT04740723Metavention30
撤回
不适用
Renal Denervation in Patients With Chronic Heart FailureCardio-Renal SyndromeChronic Heart FailureNCT02085668University Hospital, Saarland