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临床试验/NCT03142126
NCT03142126已完成不适用

Angioseal Groin Management After Left Heart Catheterization

Henry Ford Health System0 个研究点目标入组 28 人开始时间: 2014年8月6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
28
主要终点
Failure of device to achieve hemostasis

研究概览

简要总结

The researchers are seeking to study whether or not there is benefit in keeping patients flat after Angioseal for extended periods of time after diagnostic heart catheterization or if a more aggressive approach of early ambulation would be just as safe while improving cost and patient comfort.

详细描述

Diagnostic left heart catheterization is the gold standard to assess coronary anatomy. A number of post procedure closure devices have been used in order to be able to ambulate patients after the procedure. Without closure device of the arterial sheath the typical time a patient must lay flat following a diagnostic left heart catheterization at Providence hospital is approximately six hours. This extended time of having to lie flat for the patient is both uncomfortable and time consuming for hospital employees.

The Angioseal closure device is a vascular plug that has been approved by the FDA in order to seal the femoral artery arteriotomy and allow for a faster ambulation time after cardiac catheterization. Currently, the Angioseal device has been approved for ambulation times of 20 minutes after diagnostic left heart catheterization but a more conservative approach is typically used after device. A very common strategy after Angioseal is to keep the patient flat for 2 hours prior to ambulation and then to keep the patient another hour after ambulation for observation of the femoral site.

While a conservative strategy may be considered safer to the operator the Angioseal device has already been approved for an early ambulation strategy. The goal of this study is to reaffirm the safety and efficacy of using Angioseal for early ambulation. If early ambulation is performed it could improve patient comfort and even reduce cost.

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

入选标准

  • Patients undergoing diagnostic left heart catheterization.

排除标准

  • Patients who do not meet criteria for Angioseal closure after diagnostic left heart catheterization.

结局指标

主要结局

Failure of device to achieve hemostasis

时间窗: 20 minutes after procedure

Continued bleeding after deployment prior to discharge

次要结局

  • Groin hematoma(7-10 days after discharge)
  • Pseudoaneurysm(7-10 days after discharge)

研究者

申办方类型
Other
责任方
Sponsor

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