StatSeal vs Figure-of-Eight Suture for Vascular Closure in AF Ablation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 160
- 试验地点
- 6
- 主要终点
- Time to ambulation (TTA) after sheath removal
研究概览
简要总结
This study, titled aims to compare two vascular closure techniques after catheter ablation for atrial fibrillation (AF). Catheter ablation is a common procedure used to treat AF, but after the procedure, It is important to close the access site in the blood vessel to prevent bleeding. This study will evaluate whether the StatSeal device, a haemostatic disc, can help patients recover more quickly compared to the traditional figure-of-eight suture technique.
The primary objective of the study is to determine whether StatSeal reduces the time it takes for patients to start walking after the procedure (known as Time to Ambulation). Secondary objectives include comparing the time to complete haemostasis, discharge eligibility, incidence of adverse events, and patient comfort between the two techniques.
Participants in the study will be randomly assigned to receive either the StatSeal device or the figure-of-eight suture after their AF ablation procedure. The study will recruit 160 participants across multiple hospital sites, with 80 participants in each group. Both techniques are standard methods, and participants will be closely monitored for safety throughout the study.
By comparing these two closure techniques, the study aims to improve the recovery process for patients undergoing AF ablation and provide evidence on which method leads to better outcomes and patient experiences.
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
- •Male and female 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 3 femoral venous access sites
- •Willing and able to give informed consent
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
- •History of bleeding diathesis, coagulopathy, hypercoagulability, or thromboembolic events
结局指标
主要结局
Time to ambulation (TTA) after sheath removal
时间窗: 1 day
Time to ambulation is defined as the elapsed time between removal of the final sheath and the moment when the patient can stand and walk 20 feet without evidence of venous re-bleeding from the femoral access site.
次要结局
- Time to haemostasis(1 day)
- Time to discharge eligibility(1 day)
- Time to discharge(1 day)
- Incidence of major periprocedural adverse events(1 day)
- Incidence of major adverse events(30 days)
- Incidence of minor adverse events(30 days)
- Comparison of EuroQol EQ-5D-5L(30 days)