Utility of the Perclose ProGlide™ Suture-Mediated Closure Device After Cardiologic Procedures Via the Femoral Vein Approach ( Eight-CLOVER Trial)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Time to Ambulation
研究概览
简要总结
The purpose of this study is to evaluate the clinical efficacy and safety of the Perclose ProStyle™ Suture-Mediated Closure Device in patients undergoing cardiologic procedures via a femoral vein approach using a sheath size of 8 French or larger.Patients receiving cardiac interventions-such as atrial fibrillation catheter ablation, leadless pacemaker insertion, atrial septal defect (ASD) patch closure, or left atrial appendage occlusion (LAAO)-will be randomly assigned in a 1:1 ratio to either the intervention group (using the Perclose ProStyle™ device for vascular closure) or the control group (using conventional manual compression or figure-of-eight suture).The primary outcome of the study is the time to ambulation after the procedure. Secondary outcomes include time to hemostasis, time to discharge eligibility, patient satisfaction scores, and the incidence of vascular complications within 30 days post-procedure.
详细描述
Cardiac interventional procedures using large-bore sheaths (>= 8 French) via femoral vein access are associated with an increased risk of vascular access-related complications, prolonged bed rest, and delayed ambulation. While suture-mediated vascular closure devices like Perclose ProStyle™ have shown benefits in reducing hemostasis and recovery times in Western populations, prospective multi-center data in Korean patients remain limited.This prospective, randomized, open-label, parallel-group multi-center study aims to enroll a total of 200 patients across Ewha Womans University Mokdong Hospital and Seoul Hospital. Patients will be evaluated at baseline, on the day of the procedure, prior to discharge, and via a 30-day follow-up visit or phone call to assess safety and efficacy endpoints.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 19 years or older undergoing cardiologic procedures via femoral vein access
- •Patients who provide written informed consent to participate in the study
排除标准
- •Patients with active systemic infection or local infection at the vascular access site
- •Patients with known severe allergy to contrast media or device components
- •Patients unable to provide informed consent
研究组 & 干预措施
experimental Group (Perclose ProStyle)
Patients undergoing cardiologic procedures via femoral vein access who receive vascular closure using the Perclose ProStyle™ device
干预措施: Perclose ProStyle™ Suture-Mediated Closure System (Device)
Control Group (Conventional Closure)
Description: Patients undergoing cardiologic procedures via femoral vein access who receive conventional vascular closure (manual compression or figure-of-eight suture)
干预措施: Conventional Hemostasis (Manual Compression or Figure-of-Eight Suture) (Other)
结局指标
主要结局
Time to Ambulation
时间窗: Up to 24 hours post-procedure
Time elapsed from sheath removal until the patient achieves full ambulation
次要结局
未报告次要终点