NCT04632641

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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 1. WATCHMAN® device placement 2. Atrial fibrillation/flutter/SVT (supraventricular tachycardia) ablation using cryoballoon or laser balloon 3. Leadless pacemaker 4. Pulmonary embolism thrombectomy (Inari FlowTriever system) 5. 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

Conditions

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

Interventions

Type	Name	Description
DEVICE	Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES	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.
OTHER	Figure 8 Suture - LARGE-BORE PROCEDURES	A figure 8 suture will be done as a closure strategy in order to achieve hemostasis in large-bore procedures.

Timeline

• Start date: 2021-04-23
• Primary completion: 2022-12-31
• Completion: 2023-12-31
• First posted: 2020-11-17
• Last updated: 2024-10-03
• Results posted: 2024-05-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study