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临床试验/NCT03546439
NCT03546439已完成不适用

VAscular Closure for Cardiac Ablation Registry (VACCAR)

Saint Luke's Health System1 个研究点 分布在 1 个国家目标入组 434 人开始时间: 2017年10月25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
434
试验地点
1
主要终点
Ambulation

研究概览

简要总结

The objective of this registry is to find out if there is a difference in patient satisfaction and rate of vascular and bleeding complications with use of Perclose Proglide system or F08S for venous closure post atrial fibrillation and atrial flutter procedures in comparison to manual compression.

详细描述

Vascular Closure Devices (VCD) have been used to achieve hemostasis of arterial access sites following cardiac catheterization procedures. There is extensive literature available supporting the use of these devices for arterial access site closure, showing reduced time to hemostasis, earlier ambulation and reduced length of hospital stay in comparison to manual compression which is the traditional approach to achieve access site hemostasis. In contrast, there is not significant evidence supporting the use of these devices for closure of femoral venous access site, partly due to limited use of VCD in cardiac electrophysiology procedures, such as catheter ablation for atrial fibrillation and atrial flutter. Another alternative to manual compression, the Figure of 8 stitch has also been used to achieve vascular closure follow catheter ablation of atrial fibrillation and atrial flutter, however it has not been studied formally.

The aim of this registry is to better understand the 'real-world' utilization of VCD or Figure of 8 stitch(F08S) in cardiac ablation procedures and to understand any potential difference between VCD or F08S and manual compression. The outcomes of interest are vascular access site complication rate, time to ambulation and patient perception of pain and overall satisfaction, which is assessed via a survey. The hypothesis of this registry is that there will be an increased patient satisfaction and decreased rate of vascular and bleeding complications with use of either Perclose Proglide system or Figure of 8 stitch for venous closure post atrial fibrillation ablation and atrial flutter ablation procedures in comparison to standard manual compression.

The design will be a prospective observational registry collecting data on patients who underwent catheter ablation for atrial fibrillation and atrial flutter, including administration of a patient survey.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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 a catheter ablation procedure (radiofrequency ablation or cryoablation) to treat symptomatic paroxysmal atrial fibrillation or atrial flutter
  • Patients willing to participate in a short written survey

排除标准

  • Patients undergoing ablation for an arrhythmia other than atrial fibrillation/atrial flutter or who are not candidates for an ablation procedure for treatment of atrial fibrillation/atrial flutter
  • Patients who are not able to read or understand the English language
  • Patients who had recent access site complications within the same hospitalization
  • Patients who have baseline thrombocytopenia (platelet count less than 80) or known coagulopathy (INR > 1.5)

结局指标

主要结局

Ambulation

时间窗: 2 days

Time to ambulate following hemostasis measured in hours

Complications

时间窗: 2 days

Number of bleeding and vascular complications

Hospital Stay

时间窗: 2 days

Length of hospital stay in hours

Hemostasis

时间窗: 2 days

Time to achieve hemostasis measured in minutes

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 (1)

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