Same-Day Discharge Versus Overnight Stay Following Pulmonary Vein Isolation for Atrial Fibrillation - the SHAzAM-AF Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 270
- 试验地点
- 2
- 主要终点
- 30 Day vascular access-related adverse events
研究概览
简要总结
Prospective, randomized, controlled, multicentre study to compare the safety and efficacy of a Same Day Discharge (SDD) protocol in combination with a Perclose ProStyle (PPS) /ProGlide (PPG) suture mediated vascular closure device to the current gold standard: an overnight stay (ONS) protocol associated with manual compression ± figure-of-eight suture for the patients receiving interventional pulmonary vein isolation (PVI).
详细描述
The aim of the study is to prove that the use of a SDD protocol does not lead to a higher rate of adverse events (minor and major), unplanned medical visits (emergency department or outpatients' clinic) and unplanned readmissions, while substantially reducing the costs associated with the medical care and increasing the comfort of the patients on a period of 30 days, when compared to ONS and manual compression ± figure-of-eight suture. Moreover, the safety, efficiency, and feasibility of the SDD protocol should be proven during a follow-up (FU) period of 12 months. The definition of endpoints will be trained in all participating study sites to preserve consistency.
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 years
- •Elective catheter ablation for atrial fibrillation using 6 to 14 Fr inner diameter introducer sheath with a minimum of 1 and maximum of 2 femoral venous access sites, independent of the energy source use
排除标准
- •Active systemic or cutaneous infection, or inflammation in vicinity of the groin
- •Platelet count < 50,000 cells/mm3
- •Body mass index (BMI) > 45 kg/m2 or < 18 kg/m2
结局指标
主要结局
30 Day vascular access-related adverse events
时间窗: 30 days post intervention
Primary Safety Endpoint
Time to ambulation
时间窗: 2 Days after intervention
Primary Efficacy Endpoint elapsed time between removal of the final closure device or removal of final sheath and the moment when the patient stood and walked 20 ft without evidence of venous re-bleeding from the femoral access site (time to ambulation; TTA)
次要结局
- Quality of Life assessment - EQ-5D-5L(12 Month after Intervention)
- Quality of Life assessment - AFEQT(12 Month after Intervention)
研究者
Roland Richard Tilz, MD
Prof. Dr. univ. med.
University of Luebeck