Suture Closure AFtEr VEIN Access for Cardiac Procedures (SAFE-VEIN) Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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This study will be a prospective, randomized study of patients who are undergoing one or more of the following procedures at ASLMC: Large-Bore Procedures >13 F WATCHMAN® device placement Atrial fibrillation/flutter/SVT 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: Large-bore (14F-25F) venous access group (1:1) Perclose ProGlide SMC Figure 8 suture

Official Title
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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

Conditions
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Atrial Fibrillation, Atrial Flutter, Heart Block, Pulmonary Embolism and Thrombosis, Mitral Valve Repair, Sinus Node Dysfunction, Bradycardia, Brady-tachy Syndrome

Intervention / Treatment
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* Device: Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES
* Other: Figure 8 Suture - LARGE-BORE PROCEDURES


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 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 approval through December 2022. All arterial line access should be radial. Exclusion criteria: 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 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES<br>Perclose ProGlide Suture-Mediated Closure System (SMC) will be used as closure strategy for venous access sites using sheath sizes greater than 13F. | Device: Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES<br>* The Perclose ProGlide Suture-Mediated Closure System (SMC) will be used to close the vein access site(s) at the completion of the large-bore procedure in order to achieve hemostasis.<br>|
| Active Comparator: Figure 8 Suture - LARGE-BORE PROCEDURES<br>Figure 8 suture will be used as a closure technique for venous access sites using sheath sizes greater than 13F. | Other: Figure 8 Suture - LARGE-BORE PROCEDURES<br>* A figure 8 suture will be done as a closure strategy in order to achieve hemostasis in large-bore procedures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to achieve hemostasis | The elapsed time between device removal and first observed and confirmed venous hemostasis | Day 1 | 
| Time to ambulate | 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. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to discharge (TTD)/length of stay (LOS) | The elapsed time between removal of the final sheath, and the ability of subjects to be discharged. Total length of hospital stay. | up to 5 days post procedure | 
| Post procedure major bleeding | Bleeding associated with ≥2 g/dl drop in hemoglobin level requiring transfusion, bleeding that occurs at a critical site, or bleeding contributing to death. | up to 30 days post procedure | 
| Minor bleeding | Any bleeding that does not meet the criteria for major bleeding | up to 30 days post procedure | 
| Access site complications | Access site hematoma, vascular thrombosis, vascular dissection, pseudoaneurysm, or AV fistula | up to 30 days post procedure | 
| Mortality | Mortality due to vascular complications | up to 30 days post procedure |