Venous Vascular Closure System Versus Manual Compression Following Single Shot Device AF Ablation - the Style-AF Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 125
- 试验地点
- 6
- 主要终点
- Time to ambulation
研究概览
简要总结
Prospective, randomized, controlled, multi-center study to compare the safety and efficacy of the Perclose ProStyle suture-mediated closure device (PPS) as to manual compression (MC) for venous hemostasis following single shot device (SSD) based pulmonary vein isolation (PVI).
详细描述
The aim of this study is to show that the time to ambulation after PVI can be reduced by deploying vascular closure device versus manual compression and a figure-of-8 suture only. Safety, efficacy and feasibility of the PPS device should be proven, too.
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
- •Patients age >18
- •Elective catheter ablation for atrial fibrillation using a 6 to 14 Fr inner diameter introducer sheath with a minimum of 1 and maximum of 2 femoral venous access sites
排除标准
- •Active systemic or cutaneous infection, or inflammation in vicinity of the groin
- •Platelet count < 100,000 cells/mm3
- •BMI > 45 kg/m2 or < 20 kg/m2
- •Attempted femoral arterial access or inadvertent arterial puncture
- •Procedural complications that interfered with routine recovery, ambulation, or discharge times
- •Incorrect sheath placement
- •Intraprocedural bleeding or thrombotic complications
- •Access site-specific eligibility criteria to exclude problems with gaining access or location of sheath
结局指标
主要结局
Time to ambulation
时间窗: 6 hours
elapsed time between removal of the final closure device or removal of the final sheath and when the patient can stand and walk 20 ft without evidence of venous re-bleeding from the femoral access site.
次要结局
- time to hemostasis(6 hours)
- time to discharge eligibility(3 days)
- Incidence of major adverse events(30 days)
- total post procedure time(6 hours)
- time to discharge(3 days)
- Incidence of minor adverse events(30 days)
- time to closure eligibility(6 hours)
- Time to final hemostasis(3 days)
研究者
Prof. Roland Richard Tilz
Clinical Professor, Head of Rhythmology
University of Luebeck