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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
107
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.
A figure 8 suture will be done as a closure strategy in order to achieve hemostasis in large-bore procedures.
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Time to Achieve Hemostasis
The elapsed time between "device" removal and first observed and confirmed venous hemostasis
Time frame: 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.
Time frame: Day 1
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.
Time frame: 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.
Time frame: up to 30 days post procedure
Minor Bleeding
Any bleeding that does not meet the criteria for major bleeding
Time frame: up to 30 days post procedure
Access Site Complications
Access site hematoma, vascular thrombosis, vascular dissection, pseudoaneurysm, or AV (arteriovenous) fistula
Time frame: up to 30 days post procedure
Mortality
Mortality due to vascular complications
Time frame: up to 30 days post procedure
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