NCT05198674进行中（未招募）不适用
The SPYRAL AFFIRM Global Clinical Study of Renal Denervation With the Symplicity Spyral Renal Denervation System in Subjects With Uncontrolled Hypertension (SPYRAL AFFIRM)
Medtronic Vascular101 个研究点 分布在 3 个国家目标入组 1,899 人开始时间: 2021年10月20日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,899
- 试验地点
- 101
- 主要终点
- The Primary endpoint of office Systolic Blood Pressure (SBP) change at 6 months.
研究概览
简要总结
The purpose of this single-arm interventional study is to evaluate the long-term safety, efficacy, and durability of the Symplicity Spyral system in subjects treated with renal denervation.
Additionally, long-term follow-up data will also be collected from eligible subjects previously treated in the SPYRAL PIVOTAL-SPYRAL HTN-OFF MED and SPYRAL HTN-ON MED studies.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individual is diagnosed with hypertension and has a baseline office systolic blood pressure ≥140 mmHg
- •Individual has a baseline office diastolic blood pressure ≥ 90 mmHg
- •Individual has an average systolic baseline home blood pressure ≥135 mmHg
排除标准
- •Individual lacks appropriate renal artery anatomy
- •Individual has undergone prior renal denervation
- •Individual has a documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement
- •Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea
- •Individual has an estimated glomerular filtration rate (eGFR) of <45
- •Individual has one or more episode(s) of orthostatic hypotension
- •Individual is pregnant, nursing or planning to become pregnant
- •Individual has primary pulmonary hypertension
- •Individual has documented type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus with glycosylated hemoglobin greater than 8.0%
研究组 & 干预措施
Main Cohort: Renal Denervation
Experimental
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
干预措施: Renal Denervation (Symplicity Spyral™) (Device)
结局指标
主要结局
The Primary endpoint of office Systolic Blood Pressure (SBP) change at 6 months.
时间窗: 6 months
The Primary endpoint of office Systolic Blood Pressure (SBP) change at 6 months will be assessed for all patients in the Main Study Cohort
次要结局
- Percent of subjects achieving blood pressure control as measured by OBP, HBP and ABPM(From baseline to 3, 6, 12, 24, and 36 months post-procedure)
- Time subject's blood pressure is controlled(Procedure to 36 months post-procedure)
- Change in number of anti-hypertensive medications taken from baseline(From baseline to 3, 6, 12, 24, and 36 months post-procedure)
- Change from baseline in EQ-5D quality of life score(From baseline to 3, 6, 12, 24, and 36 months post-procedure)
- Change from baseline in hypertension health status score(From baseline to 3, 6, 12, 24, and 36 months post-procedure)
- Evaluate pre-specified subgroups (Chronic Kidney Disease, Diabetes Mellitus Type II, etc) as predictors for change in blood pressure as measured by OBP, HBP and ABPM(From baseline to 3, 6, 12, 24, and 36 months post-procedure)
- Evaluation of slope of eGFR(From baseline to 3, 6, 12, 24, and 36 months post-procedure)
- Incidence of events, including major adverse events(From baseline to 3, 6, 12, 24, and 36 months post-procedure)
- Office Systolic Blood Pressure change(From baseline to 3, 6, 12, 24, and 36 months post-procedure)
- Home Blood Pressure change (Main Cohort Only)(From baseline to 3, 6, 12, 24, and 36 months post-procedure)
- Change in blood pressure as measured by 24-hour ABPM(From baseline to 3, 6, 12, 24, and 36 months post-procedure)
研究者
研究点 (101)
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