The "Global Paradise® System" Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 85
- 主要终点
- Incidence of all-cause mortality
研究概览
简要总结
The GPS Registry is a multi-centre, single-arm, non-interventional (observational) registry. In addition to collecting data from patients treated as per standard clinical practice, the Registry will also regularly collect telemetric Home Blood Pressure (HBP) measurements and Patient Reported Outcome (PRO) data via a standardized quality of life questionnaire. The objective of the GPS Registry is to document the long-term safety and effectiveness of the commercially available Paradise Ultrasound Renal Denervation System when used per its labelling in patients deemed to be candidates for RDN as per physician's assessment.
详细描述
Renal denervation (RDN) by way of ultrasound is is a catheter-based technique to deliver ultrasound energy to thermally ablate and disrupt the renal efferent and afferent sympathetic nerves while sparing the renal arterial wall. The ReCor Medical ParadiseTM Ultrasound Renal Denervation System (ParadiseTM System) is a product admitted for clinical use implementing this technique. The goal of ultrasound renal denervation (ultrasound RDN) is to achieve a reduction in sympathetic over-activity with the resultant effect of reducing systemic arterial blood pressure (BP), and mitigating resultant end organ damage. With the expected increase in the number of patients to be treated in clinical practice with ultrasound RDN, and the importance of collecting real-world data on the long-term use and performance of ultrasound RDN through the use of the ParadiseTM System in a large population of patients, the Global ParadiseTM System (GPS) Registry has been set-up
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
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
- •Appropriately signed and dated informed consent
- •Age ≥18 at time of consent
- •Patient candidate for renal denervation with the Paradise System based on physician's assessment OR Patient treated with the Paradise Ultrasound Renal Denervation System within the 6 months prior to consent
排除标准
- •Patients who meet any of the contraindications listed in the Instructions for Use will be excluded.
- •The contraindications are:
- •Stented renal artery
- •Less than 18 years of age
- •Known allergy to contrast medium
- •Renal arteries diameter < 3 mm and > 8 mm
- •Renal artery with Fibromuscular (FMD) disease
- •Renal artery aneurysm
- •Renal artery stenosis of any origin >30%
- •Iliac/femoral artery stenosis precluding insertion of the Paradise catheter
结局指标
主要结局
Incidence of all-cause mortality
时间窗: Through 5 Years post-procedure
Rate of mortality attributed to any causality as per site standard practice.
New renal artery stenosis
时间窗: Through 5 Years post-procedure
\>70% confirmed by CTA/MRA as per site standard practice.
Incidence of new onset end-stage renal disease
时间窗: Through 5 Years post-procedure
eGFR\<15 mL/min/m2 or need for renal replacement therapy as per site standard practice
Significant decline in renal function
时间窗: Through 5 Years post-procedure
≥50% increase in serum creatinine (mg/dL)
Change from enrollment in quality of life scores as measured by the 12-item Short Form Health Survey (SF-12)
时间窗: Through 5 Years post-procedure
The 12-item Short Form Health Survey (SF-12) is a measure of health-related quality-of-life. Scores for each domain range from 0 to 100, with a higher score indicating a more favorable health state.
Percentage of subjects who are controlled according to current guidelines
时间窗: Through 5 Years post-procedure
Percentage of subjects who are controlled according to current guidelines as per site standard practice.
Change in office/home/ambulatory pulse pressure in mmHg
时间窗: Through 5 Years post-procedure
Rate change in office/home/ambulatory pulse pressure in mmHg as per site standard practice.
Change in office/home/ambulatory heart rate in bpm
时间窗: Through 5 Years post-procedure
Change in office/home/ambulatory heart rate in bpm as per site standard practice.
Percentage of subjects without any anti-hypertensive treatment with analysis stratified by number of enrollment antihypertensive medications
时间窗: Through 5 Years post-procedure
Rate percentage of subjects without any anti-hypertensive treatment with analysis stratified by number of enrollment antihypertensive medications per site standard practice.
Analysis of quarterly Home BP in mmHg
时间窗: Through 5 Years post-procedure
Analysis of quarterly Home BP in mmHg as per site standard practice.
Incidence of new onset stroke, TIA or CVA
时间窗: Through 5 Years post-procedure
Incidence of new onset stroke, TIA or CVA as per site standard practice.
Incidence of acute myocardial infarction
时间窗: Through 5 Years post-procedure
Incidence of acute myocardial infarction as per site standard practice.
Incidence of any coronary revascularization
时间窗: Through 5 Years post-procedure
Rate of any coronary revascularization as per site standard practice.
Reduction in average home systolic/diastolic BP in mmHg as compared to enrollment
时间窗: Through 5 Years post-procedure
Rate of reduction in average home systolic/diastolic BP in mmHg as compared to enrollment as per site standard practice.
Reduction in average office systolic/diastolic BP in mmHg as compared to enrollment
时间窗: Through 5 Years post-procedure
Rate of reduction in average office systolic/diastolic BP in mmHg as compared to enrollment as per site standard practice.
Incidence of renal artery perforation or dissection requiring an invasive intervention
时间窗: Through 5 Years post-procedure
Rate of renal artery perforation or dissection attributed to any causality as per site standard practice.
Incidence of major vascular complications (e.g, clinically significant groin hematoma, arteriovenous fistula, pseudoaneurysm) requiring surgical repair, interventional procedure, thrombin injection, or blood transfusion as per site standard practice
时间窗: Through 5 Years post-procedure
Rate of renal major vascular complications attributed to any causality as per site standard practice.
Incidence of hospitalization for hypertensive crisis or symptomatic hypotension
时间窗: Through 5 Years post-procedure
Hospitalization for hypertensive crisis or symptomatic hypotension as per site standard practice.
Incidence of hospitalization for major cardiovascular- or hemodynamic-related events (e.g. HF; AF)
时间窗: Through 5 Years post-procedure
Hospitalization for major cardiovascular- or hemodynamic-related events as per site standard practice.
Reduction in average ambulatory systolic/diastolic BP in mmHg (daytime, nighttime and 24-hr) as compared to enrollment
时间窗: Through 5 Years post-procedure
Rate of reduction in average ambulatory systolic/diastolic BP in mmHg (daytime, nighttime and 24-hr) as compared to enrollment as per site standard practice.
Incidence of home systolic BP reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg
时间窗: Through 5 Years post-procedure
Rate of incidence of home systolic BP reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg as per site standard practice.
Incidence of office systolic BP reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg
时间窗: Through 5 Years post-procedure
Rate of incidence of office systolic BP reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg as per site standard practice.
Incidence of ambulatory systolic BP (daytime/24-hr/night-time) reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg
时间窗: Through 5 Years post-procedure
Rate of incidence of ambulatory systolic BP (daytime/24-hr/night-time) reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg as per site standard practice.
次要结局
未报告次要终点