The Recor Paradise System™ Hypertension Coverage With Evidence Development Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Assessment for Changes in Blood Pressure
研究概览
简要总结
The RADIANCE CED study is a prospective observational study designed to evaluate the long-term effectiveness of ultrasound renal denervation in lowering blood pressure among patients with uncontrolled hypertension. Data will be collected from electronic health records (EHRs) of Medicare-eligible patients to support generalizability of outcomes to the broader Medicare population. Individual hospital enrollment is not required for this study and IRB exemption has been received by sponsor.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Common Inclusion Criteria:
- •Adults aged ≥65 years with uncontrolled hypertension
- •Stable regimen of blood pressure-lowering medication
排除标准
- •Hypertension due to secondary causes
- •Prior renal denervation treatment
- •Pregnancy
- •End-stage renal disease, dialysis, or kidney transplant
研究组 & 干预措施
Exposure Group (uRDN + SOC)
A procedure or device code for the Paradise™ ultrasound renal denervation system (uRDN) and medication records indicating receipt of blood pressure-lowering medications.
干预措施: Ultrasound Renal Denervation (Paradise™ Ultrasound Renal Denervation (uRDN) System) (Device)
Comparator Group (SOC)
Medication records indicating receipt of blood pressure-lowering medications.
结局指标
主要结局
Assessment for Changes in Blood Pressure
时间窗: November 2025 - December 2029
次要结局
- Occurrence of Adverse Cardiovascular and Cerebrovascular Event(November 2025 - December 2029)
- Changes in Anti-Hypertensive Medication(November 2025 - December 2029)