Atrial Fibrillation Clinical Trial
Official title:
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
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.
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 ;
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