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

Korábbi kezelés

• 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

Más betegség

• Patients with intra-procedural bleeding around access site. Patients who cannot receive radial arterial line access.
• Active systemic or cutaneous infection, or inflammation in vicinity of the groin
• Pre-existing immunodeficiency disorder or chronic use of high dose systemic steroids

Laborértékek

• Known history of bleeding diathesis, coagulopathy, hypercoagulability or platelet count < 100,000 cells/mm3

Egyéb

• 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 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
• Severe co-existing morbidities with life expectancy less than 12 months
• 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)

• 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 2022. All arterial line access should be radial.