A Prospective Randomized Study Comparing the Time to Ambulation (TTA) and Safety of Using a Closure Device Alone and in Conjunction With a Potassium Ferrate Pad (StatSeal Advanced) Following Transcatheter Aortic Valve Replacement (TAVR) Via the Transfemoral Artery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Time to Hemostasis
研究概览
简要总结
The purpose of this clinical study is to compare how well two different devices achieve hemostasis in patients undergoing a transfemoral transcatheter aortic valve replacement. Both devices are approved by the FDA for this use, and have already been used by clinicians on patients undergoing transfemoral procedures. It is believed that the use of both devices in combination compared to the Perclose alone will shorten the time that it takes to 'seal' the artery, resulting in a shorter period of time that manual pressure will be held, shorter procedure time and less complications after the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •Delivery of a 14-16 French Transcatheter aortic valve replacement system
排除标准
- •Use of a hemostasis method or device besides PercloseTM (Perclose may not be used in situations of heavy calcification, presence of dissection, etc).
- •Use of an anticoagulant other than unfractionated heparin or bivalirudin during the procedure.
- •Any use of glycoprotein inhibitors or cangrelor.
- •Use of sheathless guides.
- •Any anticipated need for continued anticoagulation post-catheterization, including extended bivalirudin infusion.
- •Any active treatment with oral anticoagulants continued during course of procedure.
- •Presence of arteriovenous dialysis fistula in the ipsilateral leg.
- •Any physical deformity or trauma / injury of the leg that would prevent proper placement or function of the hemostasis band.
- •Inability of the patient to personally consent for the study. (no surrogate consent)
- •Cardiogenic shock, emergent procedures (high risk myocardial infarctions), or any clinical instability as assessed by the physician performing the procedure.
结局指标
主要结局
Time to Hemostasis
时间窗: 24 hours post procedure (± 1 hour)
From the time of manual compression after PercloseTM deployed until hemostasis is achieved without complication.
次要结局
- Patients With Hematoma(24 hours post procedure (± 1 hour))
研究者
Olcay Aksoy, MD
Principal Investigator
University of California, Los Angeles