Suture Closure AFtEr VEIN Access for Cardiac Procedures (SAFE-VEIN) Trial: A Randomized, Prospective Study of the Safety and Efficacy of Venous Closure Device Compared to Conventional Closure Strategies in Post Venous Access Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Time to Ambulate
研究概览
简要总结
Primary objective: To compare the safety and efficacy of closure strategies post venous access procedures.
Hypothesis: We anticipate that the use of a venous closure device will decrease the time to hemostasis (TTH), time to ambulation (TTA) and time to discharge (TTD) compared to conventional methods of closure following venous access procedure.
详细描述
This study will be a prospective, randomized study of patients who are undergoing one or more of the following procedures at ASLMC (Aurora St. Luke's Medical Center):
Large-Bore Procedures >13 F
- WATCHMAN® device placement
- Atrial fibrillation/flutter/SVT (supraventricular tachycardia) ablation using cryoballoon or laser balloon
- Leadless pacemaker
- Pulmonary embolism thrombectomy (Inari FlowTriever system)
- MitraClip transcatheter mitral valve repair
RANDOMIZATION:
Patients will be randomized into one of two venous closure groups after a clean stick has been achieved with no complications:
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
- •Large-bore (>13F) Venous Access Procedures Inclusion Criteria:
- •All patients 18 years and older who are undergoing any of the following: WATCHMAN® device placement, atrial fibrillation ablation using cryoballoon or laser balloon, leadless pacemaker, Pulmonary embolism thrombectomy (Inari FlowTriever system), MitraClip transcatheter mitral valve repair at Aurora St. Luke's Medical Center from date of IRB (Institutional Review Board) approval through December
- •All arterial line access should be radial.
排除标准
- •Large-bore (>13F) Venous Access Procedures Exclusion Criteria:
- •Patients in whom introducer sheaths >25F were used in the vein during the catheterization procedure.
- •Patients with small femoral arteries or veins (< 5 mm in diameter).
- •Patients with access sites in vascular grafts.
- •Patients with intra-procedural bleeding around access site. Patients who cannot receive radial arterial line access.
- •Patients who have complications during the procedure not related to the Perclose ProGlide SMC closure device
- •The physician determines that they must use an alternate method as the primary venous closure method other than that which the patient was randomized to
- •Active systemic or cutaneous infection, or inflammation in vicinity of the groin
- •Pre-existing immunodeficiency disorder or chronic use of high dose systemic steroids
- •Known history of bleeding diathesis, coagulopathy, hypercoagulability or platelet count < 100,000 cells/mm3
- •Severe co-existing morbidities with life expectancy less than 12 months
- •Femoral arteriotomy or femoral venotomy in < 10 days, or with any known vascular complications or residual hematoma, or with use of an intravascular closure device w/in previous 30 days
- •Planned femoral venous or arterial access within next 30 days
- •Unable to routinely walk at least 20 ft. without assistance
- •LMWH (low molecular weight heparin) within 8 hours before or after procedure
- •Pregnant and/or lactating women
- •Extreme morbid obesity (BMI > 40 kg/m2) or underweight (BMI < 20 kg/m2)
研究组 & 干预措施
Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES
Perclose ProGlide Suture-Mediated Closure System (SMC) will be used as closure strategy for venous access sites using sheath sizes greater than 13F.
干预措施: Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES (Device)
Figure 8 Suture - LARGE-BORE PROCEDURES
Figure 8 suture will be used as a closure technique for venous access sites using sheath sizes greater than 13F.
干预措施: Figure 8 Suture - LARGE-BORE PROCEDURES (Other)
结局指标
主要结局
Time to Ambulate
时间窗: Day 1
The elapsed time between removal of the final Perclose ProGlide SMC device (treatment arm) or removal of the final sheath (control arm), and the ability of subjects to stand and ambulate 20 feet without evidence of venous re-bleeding from the femoral access sites.
Time to Achieve Hemostasis
时间窗: Day 1
The elapsed time between "device" removal and first observed and confirmed venous hemostasis
次要结局
- Access Site Complications(up to 30 days post procedure)
- Minor Bleeding(up to 30 days post procedure)
- Time to Discharge (TTD)/Length of Stay (LOS)(up to 5 days post procedure)
- Mortality(up to 30 days post procedure)
- Post Procedure Major Bleeding(up to 30 days post procedure)