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临床试验/NCT06199414
NCT06199414尚未招募不适用

Vascular Closure With Novel External Compression Device After Atrial Fibrillation Ablation: The LockeT Study

Kansas City Heart Rhythm Research Foundation2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年1月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
70
试验地点
2
主要终点
Effectiveness of LockeT device - Time to Ambulate

研究概览

简要总结

Single center, retrospective review study comparing Figure of Eight suture to LockeT, enrolling approximately 70 patients.

详细描述

The volume of catheter ablation procedures for the treatment of atrial fibrillation and other arrhythmias are on the rise in the United States and worldwide. Despite refinement in ablation tools and techniques which has led to a significant decline in complication rates, achieving vascular hemostasis following femoral access with large bore sheaths remains a challenge. Manual compression (MC) the current standard of care, requires bedrest, often up to 8 hours. This prolonged bedrest is associated with longer length of stay and at times complications from indwelling catheters.

Other methods of vascular closure include figure-of-eight (F-8) a, subcutaneous suture or Z-stitch or fellow's stitch has been evaluated as a means to achieve homeostasis following major cardiovascular procedures. One pooled meta-analysis of six studies including 982 patients demonstrated that F-8 is safe and effective means of achieving hemostasis. In comparison to MC time to hemostasis was significantly lower and overall access site complications like hematoma, bleeding was also noted to be lower in F-8 group.

In recent years, invasive, vascular closure devices have become popular. However, results continue to suggest that the risk versus benefit has not been definitively demonstrated. LockeT is a new suture retention device designed to closely mimic manual compression without the need for a healthcare professional to stand bedside.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • All participants must meet the following criteria to be included in this study.
  • Subjects must be at least 18 years of age.
  • Subjects underwent Atrial Fibrillation radiofrequency ablation procedure.
  • Subjects must have undergone F-8 or LockeT for venous closure.

排除标准

  • If a subject meet any of the following criteria will be excluded from study participation.
  • Subjects under the age of
  • Subject's electrophysiology procedure is not planned to access the left atrium or ventricle.
  • Subjects in which F-8 or a LockeT was not used.
  • If the EP physician detected a formed hematoma prior to venous closure, that patient will be excluded from the study.

结局指标

主要结局

Effectiveness of LockeT device - Time to Ambulate

时间窗: 1 week

To assess the effectiveness of using LockeT to retain sutures and pressure to gain hemostasis after venous procedures. Time to no oozing/hemostasis (mins/hours)

Effectiveness of LockeT device - Time to no oozing/hemostasis

时间窗: 1 week

To assess the effectiveness of using LockeT to retain sutures and pressure to gain hemostasis after venous procedures. Time to no oozing/hemostasis (mins/hours)

次要结局

未报告次要终点

研究者

发起方
Kansas City Heart Rhythm Research Foundation
申办方类型
Other
责任方
Sponsor

研究点 (2)

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