跳至主要内容
临床试验/NCT03458988
NCT03458988已完成不适用

Pilot Study to Validate a Novel Blood-pressure Measuring Device in Patients Carrying a Left Ventricular Assist Device

Insel Gruppe AG, University Hospital Bern2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年2月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
RR (Riva Rocci, indirect blood pressure measurement) in LVAD

研究概览

简要总结

To prove the novel device is able to reliably detect pulsatility in patients with CF-VADs and to analyze whether pre-programmed intrinsic pulsatility of the 3rd generation CF-VADs can also be picked up. The study is not designed to measure blood pressure.

Should this pilot study be successful in detecting enough pulsatility a follow-up study would then try to transfer the results into blood-pressure values with the help of comparators in order to identify an easier and more reliable method to measure BP in CF-VAD patients. .

详细描述

The number of patients supported by left ventricular assist device (LVAD) is increasing as durable mechanical support has become widely available for end stage heart failure as destination therapy and as bridge to transplantation. The accurate measurement of blood pressure (BP) as well as the recognition and management of hypertension in patients with LVADs is an essential component of optimal clinical care. Hypertension is an established long-term risk factor for cardiovascular disease. The measurement of BP and the management of hypertension in patients with CF-VADs can present unique challenges. Patients with LVADs often do not have a palpable pulse, and therefore traditional BP measurement by auscultation or automated cuff is less reliable. Conventional occlusive BP measurement is able to to pick up signals in approximately 50% of cases due to coincidental phases of pulsatility. The arterial line is the gold standard, but is an invasive procedure and not practical for routine outpatient use.

Although efforts are underway to identify an easier and more reliable method to measure ambulatory BP in these patients not one has been able to match the quality of an invasive arterial line.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

入选标准

  • Patients carrying one of the two third generation CF-VADS (Heartware HVAD, Heartmate 3)
  • Patients >18y
  • Good understanding of written and oral German
  • Signed informed consent
  • Scheduled for routine outpatient appointment.

排除标准

  • In the population of the outpatient clinic's CV-LVAD patients no known exclusion criteria exists

结局指标

主要结局

RR (Riva Rocci, indirect blood pressure measurement) in LVAD

时间窗: 10 min blood measuring

Detect pulsatility in CF-VAD (Continuous flow- ventricular assist device) patients sufficient to calculate comprehensible blood-pressure values in future follow-up studies

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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