跳至主要内容
临床试验/NCT03040661
NCT03040661已完成不适用

Randomized Trial of Femoral Vein Hemostasis After Ablation for Atrial Fibrillation With Manual Pressure Versus a Figure of 8 Suture

Inova Health Care Services2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2017年3月1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
70
试验地点
2
主要终点
Time Required to Achieve Hemostasis

研究概览

简要总结

Patients who undergo ablation for AF typically have 2 sheaths placed in each groin, including a large sheath when the Cryo Balloon is used for pulmonary vein isolation. During the procedure, heparin is administered to maintain a target ACT > 300 seconds. At the conclusion of the procedure, the venous sheaths are removed and hemostasis is obtained. There are at least 2 ways of obtaining hemostasis after venous access. In the manual hemostasis approach, an ACT is checked and protamine is administered. The ACT is rechecked 20" later, and if < 220 msec, the sheaths are pulled and hemostasis is achieved with manual pressure (Manual Hemostasis Group). Another approach is to place a Figure of 8 suture around the sheaths in each groin to achieve hemostasis as the sheaths are removed, and therefore obviate the need for assessment of the ACT, protamine administration, and manual pressure (Figure of 8 Group).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
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

  • Any patient who meets standard clinical criteria for an ablation of AF with Cryoballoon, and is to undergo the procedure

排除标准

  • Pregnant patients.
  • Age <18 years.
  • Patients who cannot provide consent in English.

结局指标

主要结局

Time Required to Achieve Hemostasis

时间窗: Time (minutes) from sheath removal till hemostasis achieved

Time Required to Achieve Hemostasis (minutes)

Time Required From the Completion of the Ablation Portion of the Procedure Until the Patient Leaves the EP Lab.

时间窗: Time (minutes) from completion of procedure till patient leaves room

Time required from the completion of the ablation portion of the procedure until the patient leaves the EP Lab (minutes)

次要结局

  • Percent Groin Complications in Figure of 8 Suture Technique Group Compared to Manual Hemostasis Group(Assessed after sheath removal till patient discharge)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验